Zanidatamab plus chemotherapy as first-line treatment of HER2-positive advanced gastro-oesophageal adenocarcinoma

Gastro-oesophageal adenocarcinoma represents a group of malignancies comprising gastric, oesophageal, and gastro-oesophageal junction adenocarcinomas. Gastro-oesophageal adenocarcinoma remains one of the ...

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Cabozantinib plus Atezolizumab in metastatic prostate cancer. Final analyses from CONTACT-02

Patients with metastatic castration-resistant prostate cancer (mCRPC) with extrapelvic soft-tissue metastases that has progressed on an androgen receptor pathway inhibitor ...

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Sugemalimab versus placebo, in combination with Platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer. 4-year outcomes from GEMSTONE-302

GEMSTONE-302 was a phase 3 trial in patients with treatment-naive metastatic squamous or non-squamous non-small-cell lung cancer (NSCLC), showed significant ...

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Tepmetko based on Tepotinib for metastatic non-small cell lung cancer. FDA grants accelerated approval

Tepmetko ( Tepotinib ) was granted accelerated approval by Food and Drug Administration for adult patients with metastatic non-small ...

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Margenza based on Margetuximab for metastatic HER2-positive breast cancer. FDA has approved

The Food and Drug Administration ( FDA ) has approved Margenza ( Margetuximab-cmkb; Margetuximab ) in combination with chemotherapy, for ...

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Nemolizumab’s efficacy and rapid onset of action in prurigo nodularis

In the phase III OLYMPIA 1 trial, Nemolizumab as a monotherapy has significantly improved itch and skin lesions in adult ...

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CheckMate -67T trial of subcutaneous Nivolumab in advanced or metastatic clear cell renal cell carcinoma

The phase 3 CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo ( Nivolumab ) co-formulated with Halozyme’s recombinant ...

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Phase 3 trial of Cemiplimab as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

The primary endpoint of overall survival ( OS ) was met in a phase 3 trial comparing the PD-1 inhibitor ...

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Teclistamab, a BCMAxCD3 bispecific antibody, plus Daratumumab and hyaluronidase has improved clinical efficacy in heavily pretreated patients with relapsed or refractory multiple myeloma

Updated efficacy and safety results from the Teclistamab cohort of the phase 1b TriMM-2 study were presented at the 2022 ...

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Farxiga, a SGLT2 inhibitor, for adults with chronic kidney disease at risk of progression

Farxiga ( Dapagliflozin ) is a first-in-class, oral, once-daily SGLT2 inhibitor. The research for Farxiga is advancing from cardiorenal effects ...

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ELEKTRA Study: Soticlestat in pediatric patients with highly refractory epileptic seizures associated with Dravet syndrome and Lennox-Gastaut syndrome

ELEKTRA was an international, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate treatment with Soticlestat in pediatric patients, aged 2 ...

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Rinvoq for treatment of patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis

The European Commission ( EC ) has extended approval for Rinvoq ( Upadacitinib ) 15 mg to treat adult patients ...

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ALK-positive lung cancer with brain-only progression: Lorlatinib

Lorlatinib ( Lorviqua ) is a 3rd-generation ALK tyrosine kinase inhibitor ( TKI ) developed to penetrate the central nervous ...

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EMPEROR-Reduced trial: evaluation of the effect of Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction

Drugs that inhibit the sodium-glucose co-transporter 2 ( SGLT2 ) have been shown to reduce the risk of hospitalizations for ...

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FDA has approved Lorbrena for second- or third-line treatment of ALK-positive metastatic non-small cell lung cancer

The Food and Drug Administration ( FDA ) has granted accelerated approval to Lorlatinib ( Lorbrena ) for patients with ...

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Cancer immunotherapy: Keytruda for hepatocellular carcinoma

The FDA ( US Food and Drug Administration ) has granted accelerated approval for Keytruda ( Pembrolizumab ), an immunotherapy ...

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Opdivo plus low-dose Yervoy as first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) adopted ...

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Advanced renal cell carcinoma: Fotivda for the first-line treatment

The European Commission ( EC ) has licensed Fotivda ( Tivozanib ) for the management of adult patients with advanced ...

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Antidote for Pradaxa may be able to achieve immediate, complete and sustained reversal of Dabigatran-induced anticoagulation in healthy humans

Boehringer Ingelheim has announced results showing that its investigational fully humanized antibody fragment ( Fab ) rapidly reversed the anticoagulation ...

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Ultra long-acting beta-adrenoceptor agonist: Olodaterol for maintenance treatment of COPD

The FDA ( Food and Drug Administration ) Pulmonary-Allergy Drugs Advisory Committee ( PADAC ) has recommended that clinical data ...

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Ovarian cancer: Lynparza

Among women in Europe, ovarian cancer is the fifth most common cancer and the sixth leading cause of cancer death. ...

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Acute lymphoblastic leukaemia: Oncaspar is indicated as a component of antineoplastic combination therapy

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of ...

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Glyxambi, a single tablet that combines Empagliflozin and Linagliptin, has shown to improve blood sugar control in adults with type 2 diabetes mellitus

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has ...

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CONNECT study: Vortioxetine is an efficacious and well-tolerated treatment for patients suffering from depression

The journal Neuropsychopharmacology has published the CONNECT trial results. In the publication, the authors conclude that Vortioxetine ( Brintellix ) ...

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Efficacy of Secukinumab in patients with psoriasis of the nails, palms and soles

Secukinumab ( Cosentyx ) has met the primary endpoints in two new clinical studies, showing superior efficacy compared to placebo ...

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Solithromycin for the treatment of moderate to moderately-severe community acquired bacterial pneumonia and urethritis

Solithromycin is a next-generation oral and intravenous fluoroketolide in development for the treatment of moderate to moderately-severe community acquired bacterial ...

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Eravacycline is an antibiotic for treatment of multidrug-resistant ( MDR ) infections, including those caused by MDR Gram-negative bacteria

Eravacycline is a broad-spectrum intravenous and oral antibiotic for the treatment of multidrug-resistant ( MDR ) infections, including those caused ...

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Advanced non-small cell lung cancer: EGFR mutation testing affects choice of therapy

Results from a new global survey of lung cancer oncologists have shown that despite 81% of newly diagnosed advanced non-small ...

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Tiotropium plus Olodaterol Respimat versus Tiotropium Respimat on exacerbations in COPD

The DYNAGITO study will assess the potential benefit of Tiotropium plus Olodaterol Respimat FDC ( fixed-dose combination ) compared to ...

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Primary breast cancer: dose-density regimen with Fluorouracil, Epirubicin, and Cyclophosphamide on days 1 and 4 every 14 days with Filgrastim support followed by weekly Paclitaxel

Recent evidence has shown that use of anthracycline and taxane adjuvant chemotherapy and dose-dense regimens, consisting of more frequent administration ...

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Pediatric patients receiving targeted anticancer therapies and dermatologic adverse events

The dermatologic adverse events of various molecularly targeted therapies are well-described in adult cancer patients. Little has been reported on ...

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Non-metastatic extremity osteosarcoma: Pirarubicin-based chemotherapy displayed better clinical outcomes and lower toxicity than did doxorubicin-based chemotherapy

Pirarubicin ( THP ) is a newer generation anthracycline anticancer drug with antineoplastic efficacy against numerous tumors. Few studies have ...

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Multi-targeted receptor tyrosine kinase inhibitors: Sunitinib for the treatment of advanced thyroid cancer

In patients with advanced thyroid cancer, Sunitinib [ Sutent ], a drug approved for treatment of several other cancers, showed ...

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Anti-CGRP antibodies: TEV-48125 meets primary and secondary endpoints in chronic migraine

Positive results from a Phase IIb study evaluating the efficacy, safety and tolerability of two doses of subcutaneous TEV-48125, an ...

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Migraine treatment: CGRP receptor antagonists and antibodies against CGRP and its receptor

Recently developed CGRP ( calcitonin gene-related peptide ) receptor antagonists have shown promising results in clinical trials for acute treatment ...

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European regulatory authorities have adopted a positive opinion for Saxenda for the treatment of obesity

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has ...

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Pharmacological strategies for the management of Levodopa-induced dyskinesia in patients with Parkinson's disease

L-Dopa-induced dyskinesias ( LID ) are the most common adverse effects of long-term dopaminergic therapy in Parkinson's disease ( PD ...

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Long-term follow-up of patients with thromboangiitis obliterans treated with intravenous Iloprost

Researchers at University of Pisa ( Italy ) have evaluated the effectiveness of intravenous Iloprost ( IVI ) in outpatients ...

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Homozygous familial hypercholesterolemia: Juxtapid, a new orphan drug for rare cholesterol disorder

The FDA ( Food and Drug Administration ) approved Juxtapid ( Lomitapide ) to reduce low-density lipoprotein ( LDL ...

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Zydelig, a first-in-class oral treatment for two blood cancers: chronic lymphocytic leukemia and follicular lymphoma

The European Commission has granted marketing authorization for Zydelig ( Idelalisib ), 150 mg tablets, a first-in-class oral treatment for ...

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Pacritinib, a JAK2 inhibitor for the treatment of myelofibrosis: FDA grants fast track designation

Pacritinib has been granted Fast Track designation by the FDA ( Food and Drug Administration ) for the treatment of ...

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VIVACITO study: Tiotropium plus Olodaterol FDC has shown significant improvement in lung function

The first phase III data for the once-daily fixed-dose combination of Tiotropium and Olodaterol were presented at American Thoracic Society ...

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Lenvatinib, a thyroid cancer drug meets primary endpoint in phase 3 study

Eisai has announced that the phase 3 SELECT trial ( Study 303 ) of investigational agent Lenvatinib met its primary ...

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Methylphenidate ADHD medications may in rare instances cause priapism

The FDA ( Food and Drug Administration ) is warning that Methylphenidate products, one type of stimulant drug used to ...

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Cimzia for treatment of adults with active ankylosing spondylitis, approved by FDA

The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adults ...

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Opsumit to treat pulmonary arterial hypertension, FDA approved

The Food and Drug Administration ( FDA ) has approved Opsumit ( Macitentan ), a new drug to treat adults ...

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Abilify Maintena, a dopamine D2 partial agonist in once-monthly injectable form, for the maintenance treatment of schizophrenia in adult patients stabilised with oral Aripiprazole

Lundbeck and Otsuka Pharmaceutical have announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human ...

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European Union: Radium Ra 223 dichloride for the treatment of castration-resistant prostate cancer with bone metastases, CHMP recommended the approval

Bayer HealthCare has announced that the European Committee for Medicinal Products for Human Use ( CHMP ) recommended Radium Ra ...

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Metrogel 1% pump dispenser for the treatment of papulopustular rosacea

Galderma Laboratories has announced the availability of a new pump dispenser design for MetroGel ( Metronidazole ) Gel, 1%, the ...

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Ruxolitinib improves overall survival in Phase III trial of patients with myelofibrosis

Incyte has announced results from two ongoing clinical trials of Jakafi ( Ruxolitinib ), an oral JAK1 and JAK2 inhibitor ...

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New formulation of Herceptin approved in Europe for the treatment of HER2-positive breast cancer

Roche has announced that a new injectable ( subcutaneous ) formulation of Herceptin ( Trastuzumab ) has been approved by ...

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Prolia for the treatment of bone loss in men with osteoporosis at high risk for fracture

Amgen has announced the FDA ( Food and Drug Administration ) has approved a new indication for Prolia ( Denosumab ...

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FDA approves Xgeva for the treatment of giant cell tumor of bone

Amgen has announced that the FDA ( Food and Drug Administration ) has approved a new indication for Xgeva ( ...

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Abatacept shows comparable efficacy to Humira in year two data in patients with moderate to severe rheumatoid arthritis

Bristol-Myers Squibb ( BMS ) has announced the results of year two data from AMPLE ( Abatacept Versus Adalimumab Comparison ...

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Potiga associated with retinal abnormalities and blue skin discoloration

The FDA ( Food and Drug Administration ) has warned the public that the anti-seizure medication Potiga ( Ezogabine; Retigabine ...

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Xarelto approved in the EU for secondary prevention after an acute coronary syndrome

The oral anticoagulant Xarelto ( Rivaroxaban ) has been approved by the European Commission for the prevention of atherothrombotic events ...

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Kcentra for the urgent reversal of vitamin K antagonist anticoagulation: FDA approved

The Food and Drug Administration ( FDA ) has approved Kcentra ( Prothrombin Complex Concentrate, Human ) for the urgent ...

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Radium 223, a new treatment for castration-resistant prostate cancer patients with bone metastases

Bayer HealthCare has announced that the FDA ( Food and Drug Administration ) has approved Xofigo ( Radium 223 dichloride ...

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GAP study: IG treatment does not demonstrate a significant effect in cognitive decline in patients with mild to moderate Alzheimer's disease

Baxter International has announced that its Phase III clinical study of Immunoglobulin ( IG ) did not meet its co-primary ...

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Inspra reduces risk of cardiovascular death and heart failure hospitalization in high risk patients with chronic heart failure NYHA class II and mild symptoms

The results from a new post-hoc sub-group analysis of the EMPHASIS-HF trial have showed statistically significant reductions in the primary ...

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Samsca linked to potential risk of liver injury

Otsuka has informed of significant liver injury associated with the use of Tolvaptan ( Samsca ). In a large double-blind, ...

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Bevacizumab significantly improves survival for patients with recurrent and metastatic cervical cancer

Interim analysis of a large, randomized clinical trial has shown that patients with advanced, recurrent, or persistent cervical cancer that ...

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Aubagio for the treatment of relapsing forms of multiple sclerosis: safety information

Teriflunomide ( Aubagio ) is an immunomodulatory drug inhibiting pyrimidine de novo synthesis by blocking the enzyme dihydroorotate dehydrogenase. Teriflunomide ...

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Pneumonitis, interstitial lung disease, lung infiltration or respiratory failure suspected of being associated with Docetaxel, an antineoplastic agent

In Canada, Docetaxel ( Taxotere ) is an injectable chemotherapy drug that was first marketed on December 31, 1995. It ...

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Cardiometabolic adverse reactions suspected of being associated with second-generation antipsychotics in children and adolescents

Excess weight and obesity in the general population are increasing problems throughout the Western world, and this rise has also ...

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Daxas and risk of suicidal behaviour in patients with COPD

Roflumilast ( Daxas ) is a phosphodiesterase-type-4 ( PDE4 ) inhibitor used for maintenance treatment of severe chronic obstructive pulmonary ...

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SGLT2 inhibitors: FDA has approved Invokana to treat type 2 diabetes

The FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) tablets, used with diet and exercise, ...

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Multiple sclerosis: FDA has approved Tecfidera

The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with ...

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Xarelto recommended for approval in the EU for the prevention of atherothrombotic events after an acute coronary syndrome

The European Committee for Medicinal Products for Human Use ( CHMP ) has recommended approval of oral anticoagulant Xarelto ( ...

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Positive results of phase 3 Talimogene Laherparepvec trial in melanoma

Amgen has announced top-line results from the phase 3 trial in melanoma, which has evaluated the efficacy and safety of ...

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Incretin mimetic drugs for type 2 diabetes: possible increased risk of pancreatitis and pre-cancerous findings of the pancreas

The FDA ( Food and Drug Administration ) is evaluating unpublished new findings by a group of academic researchers that ...

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Antibacterial drugs: Azithromycin associated with risk of potentially fatal heart rhythm

The FDA ( Food and Drug Administration ) is warning the public that Azithromycin ( Zithromax or Zmax ) can ...

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Reductions in risk of CHD mortality and cardiovascular events with Simvastatin

The Heart Protection Study ( HPS ), a large, multicenter, placebo-controlled, double-blind study with a mean duration of 5 years ...

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Juvisync, a once-daily therapy for patients with type 2 diabetes who need to lower blood sugar and cholesterol

Merck has announced today that the FDA ( Food and Drug Administration ) has approved Juvisync ( Sitagliptin and Simvastatin ...

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Plaque psoriasis: Apremilast linked to significant and clinically meaningful improvements for the primary and major secondary endpoint in the ESTEEM 1 and 2 studies

Celgene has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients ...

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Kadcyla, a new treatment for late-stage breast cancer, approved in the United States

The U.S. Food and Drug Administration ) has approved Kadcyla ( Ado-Trastuzumab Emtansine ), a new therapy for patients with ...

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Stivarga for advanced gastrointestinal stromal tumors, FDA approved

The FDA ( Food and Drug Administration ) has expanded the approved use of Stivarga ( Regorafenib ) to treat ...

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Association found between long-term use of non-Aspirin anti-inflammatory drugs and renal cell cancinoma

Long-term use of non-Aspirin anti-inflammatory drugs ( NSAIDs ) is associated with an increased risk of renal cell cancer ( ...

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Aubagio a oral treatment for relapsing multiple sclerosis, approved by FDA

Genzyme, a Sanofi company, has announced that the FDA ( Food and Drug Administration ) has approved Aubagio ( Teriflunomide ...

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Prasugrel has shown 26% reduction in cardiovascular events over Clopidogrel in new core clinical cohort population sub-Analysis of the TRITON-TIMI 38 Pivotal Study

A new post-hoc sub-analysis of an important set of patients from the TRITON-TIMI 38 study, those identified as the core ...

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Sofosbuvir for hepatitis C: FISSION and NEUTRINO studies both meet primary endpoints

Gilead Sciences has announced topline results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the ...

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Increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA less than or equal to 3.0 ng/mL ...

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Non-valvular atrial fibrillation: FDA has approved Eliquis to reduce the risk of stroke and systemic embolism

The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet ...

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Avastin plus chemotherapy for patients with metastatic colorectal cancer: FDA approved

Roche has announced that the FDA ( Food and Drug Administration ) has approved a new use of Avastin ( ...

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Pertuzumab for the treatment of patients with HER2-positive metastatic breast cancer

The FDA ( Food and Drug Administration ) has approved Pertuzumab injection ( Perjeta ) for use in combination with ...

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Important safety information for Promacta

Promacta may cause hepatotoxicity. Promacta, in combination with Interferon and Ribavirin in patients with chronic hepatitis C, may increase the ...

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Promacta for patients with thrombocytopenia with chronic hepatitis C to allow the initiation and maintenance of Interferon-based therapy

GlaxoSmithKline ( GSK ) has announced that the FDA ( Food and Drug Administration ) has approved Promacta ( Eltrombopag; ...

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Dyslipidemia: Merck has suspended the availability of Tredaptive over safety concerns

Merck, known as MSD outside of the United States and Canada, has announced the company is taking steps to suspend ...

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Latuda for the treatment of patients with schizophrenia

Sunovion Pharmaceuticals has announced that the FDA ( Food and Drug Administration ) has approved Latuda ( Lurasidone HCl ) ...

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FDA: abnormal heart rhythms associated with use of Anzemet

The FDA ( Food and Drug Administration ) has informed patients and healthcare professionals that the injection form of Anzemet ...

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Cabozantinib in patients with castration-resistant prostate cancer: high rates of complete or partial bone scan resolution, pain relief, improvements in hemoglobin, and tumor regression

Exelixis has reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer ( CRPC ) treated ...

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FDA has approved Bosulif for chronic myelogenous leukemia

The FDA ( Food and Drug Administration ) has approved Bosulif ( Bosutinib ) to treat chronic myelogenous leukemia ( ...

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FDA: serious skin reactions after combination treatment with the hepatitis C drugs Incivek ( Telaprevir ), Peginterferon alfa, and Ribavirin

The Food and Drug Administration ( FDA ) has received reports of serious skin reactions, some fatal, in patients taking ...

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Avastin for the treatment of women with recurrent, Platinum-sensitive ovarian cancer: approved in Europe

Roche has announced that the European Commission ( EC ) has approved Avastin ( Bevacizumab ) in combination with standard ...

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Denosumab: fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment

Cases of severe symptomatic hypocalcaemia have occurred in patients receiving Denosumab 120 mg ( Xgeva ) or 60 mg ( ...

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Potential risk of serious skin reactions associated with the HLA-A* 3101 allele with Carbamazepine, Oxcarbazepine and Eslicarbazepine

Carbamazepine ( Tegretol ) is an antiepileptic drug that is indicated for the treatment of generalised tonic clonic seizures. Carbamazepine ...

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Information on the cardiovascular safety of non-steroidal anti-inflammatory drugs

The EMA ( European Medicines Agency ) has finalised a review of recently published information on the cardiovascular safety of ...

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Forxiga, a SGLT2 inhibitor, approved in Europe for treatment of type 2 diabetes

Forxiga ( Dapagliflozin ) is the first SGLT2 ( sodium/glucose cotransporter 2 ) class drug. Forxiga has obtained marketing approval ...

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Pediatric Crohn's disease: Humira approved in Europe

European Commission has approved Humira ( Adalimumab ) for the treatment of pediatric patients aged six to 17 years with ...

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European Union: Eylea approved for the treatment of wet age-related macular degeneration

Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ), also known as VEGF Trap-Eye, has been approved ...

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