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FDA Approves the World’s Smallest Mechanical Heart Valve for Pediatric Patients With Heart Defects

Abbott announced the U.S. FDA approved the Masters HPโ„ข 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. ...

Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

Globally, about 800 women die every day of preventable causes related to pregnancy and childbirth; 20 per cent of these women are from India,1 and Postpartum Haemorrhage (PPH) is the leading cause of maternal mortality in India. ...

European Commission approves Hemlibraยฎ (emicizumab) for people with haemophilia A with factor VIII inhibitors

Roche announced that the European Commission has approved Hemlibraยฎ (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups. Nearly one in...

Recipharm and Altus Formulation collaborate to offer novel drug delivery technologies for value added medicines

Recipharm, the contract development and manufacturing organisation (CDMO), has signed a licensing agreement with Altus Formulation Inc., a Canadian drug development company, to allow its customers to access new drug delivery technologies and products. Under the...

Lillyโ€™s Verzenio for Advanced Breast Cancer Receives Additional FDA Approval

Eli Lilly and Company announced that the U.S. FDA has approved Verzenioโ„ข in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative...

Novo Nordisk records for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A

Novo Nordisk announced the submission of a Biologics License Applications (BLA) to the US FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for N8-GP, an extended half-life factor VIII for treatment of people with...

Biogen, AbbVie draw Multiple Sclerosis Drug On Inflammation Reports

RBC analyst Brian Abrahams said the decision will have "zero material impact" on Biogen as Zinbryta was expected to bring in about $400 million in 2027 revenue for the company, or less than 3% of total sales. ...

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