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Added 10 hours ago Drug news

The PDUFA date for FDA review of Ocaliva to treat NASH is extended to 26 June 2020.- Intercept Pharma

Intercept Pharmaceuticals has stated it could take up to three months longer for regulators to make an approval decision on...

Added 10 hours ago Drug news

FDA Advisory Committees again reject Aximris XR for the management of pain.- Intellipharmaceutics International Inc.

Intellipharmaceutics International Inc. announced that that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management...

Added 10 hours ago Drug news

European Commission approval for Isturisa for the treatment of people with endogenous Cushing’s syndrome.- Recordati

Recodati‘s inhibitor of cortisol synthesis, Isturisa (osilodrostat), has been approved by the European Commission (EC) for the treatment of people...

Added 10 hours ago Drug news

DURECT Corporation announces the outcome of the FDA Advisory Committee meeting for Posimir which resulted in a split vote on the treatment of post-surgical pain .

DURECT Corporation has announced that the (FDA Anesthetic and Analesic Drug Products Advisory Committee (AADPAC) met to discuss the Class...

Added 1 day ago Drug news

FDA approves label extension for Ozempic for reduction of risk of major adverse cardiovascular events in type 2 diabetes.- Novo Nordisk

Novo Nordisk has announced that the FDA has approved a label expansion based on a supplemental New Drug Application (sNDA)...

Added 1 day ago Drug news

NICE rejects Xospata to treat AML with FLT3 mutations- Astellas

NICE (The National Institute for Health and Care Excellence) has recommended against Xospata (gilteritinib) from Astellas for patients with relapsed/refractory...

Added 1 day ago Drug news

FDA approves Ozempic for type 2 diabetes + CV risks.- Novo Nordisk

Novo Nordisk announced that the FDA has approved a new indication for Ozempic (semaglutide) injection 0.5 mg or 1 mg...