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Added 14 hours ago Drug news

Aquestive Therapeutics receives FDA response to citizen’s petition that the FDA stay approval of a NDA for Valtoco (diazepam nasal spray) submitted by Neurelis, Inc.

Aquestive Therapeutics, Inc. reported that the FDA issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition...

Added 14 hours ago Drug news

NICE rejects Vitrakvi to treat neurotrophic tyrosine receptor kinase fusion-positive solid tumours.- Bayer HealthCare

The National Institute for Health and Care Excellence (NICE) has rejected Vitrakvi (larotrectinib) from Bayer as its current price, it...

Added 1 day 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 1 day 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 1 day 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 1 day 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 2 days 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 2 days 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 2 days 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...

Added 2 days ago Drug news

NICE rejects Keytruda as a treatment of head and neck cancer.-Merck Inc.

The National Institute for Health and Care Excellence (NICE) has published a new draft guidance not recommending Keytruda (pembrolizumab) from...

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