Drug News

Added 5 hours ago Drug news

FDA accepts re filing of NDA for Macrilen (macimorelin) to treat growth hormone deficiency.- Aeterna Zentaris Inc.

Aeterna Zentaris Inc. announced that it has been notified by the FDA, that the Company’s New Drug Application seeking approval...

Added 1 day ago Drug news

EU CHMP recommends approval of Rydapt (midostaurin) for acute myeloid leukemia (FLT3 mutation-positive)- Novartis

Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion...

Added 1 day ago Drug news

EU CHMP recommends approval of Rydapt (midostaurin) for systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia- Novartis

Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion...

Added 1 day ago Drug news

EU CHMP recommends approval of Lutathera (lutetium (177Lu) oxodotreotide) in gastroenteropancreatic neuroendocrine tumors- Advanced Accelerator Applications

Advanced Accelerator Applications announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...

Added 1 day ago Drug news

EU CHMP recommends approval of Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea - Lexicon Pharmaceuticals

Lexicon Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible...

Added 1 day ago Drug news

FDA approves subcutaneous formulation of Benlysta (belimumab) for systemic lupus erythematosus- GlaxoSmithKline

The FDA has approved a new subcutaneous formulation of Benlysta (belimumab), from GlaxoSmithKline, for the treatment of adult patients with...

Added 1 day ago Drug news

EU CHMP recommends approval of Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis- Roche

The EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra/RoActemra (tocilizumab),...

Added 2 days ago Drug news

NICE extends recommendation for Strensiq (asfotase alfa) to treat people with paediatric-onset hypophosphatasia.- Alexion Pharma

NICE has published draft guidance recommending the drug asfotase alfa (also called Strensiq and made by Alexion Pharma UK) for...

Added 3 days ago Drug news

EU Commission approves Kyntheum (brodalumab) of moderate-to-severe plaque psoriasis.- Leo Pharma

AstraZeneca and MedImmune, announced that its partner Leo Pharma has been granted full marketing authorisation in all 28 EU member...

Added 3 days ago Drug news

Rolling submission to FDA started for CAM 2038 (buprenorphine depots) in Opioid Use Disorder- Braeburn Pharmaceuticals and Camurus

Braeburn Pharmaceuticals and Camurus announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S....

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