11,578 Results

Leo Pharma withdraws Picato, a treatmemt for actinic keratosis, in the EU.

 Added 20 hours ago

The European Medicines Agency (EMA) has recommended the suspension of Picato in the EU and EEA as a precautionary measure...

EU approves Darzalex + Velcade + Thalomid + dexamethasone in newly diagnosed multiple myeloma.- Genmab

 Added 20 hours ago

Genmab announced that the European Commission (EC) has granted marketing authorization for Darzalex (daratumumab) in combination with Velcade (bortezomib), Thalomid(thalidomide)...

IDMC recommends early halt of phase III SANET-p study of HMPL 012 in neuroendocrine tumors – pancreatic.- Hutchison China MediTech

 Added 20 hours ago

Hutchison China MediTech Limited announced that the independent Data Monitoring Committee of the Phase III pivotal study of HMPL 012...

European Commission approves Sunosi to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy, Jazz Pharma

 Added 20 hours ago

Jazz Pharmaceuticals plc announced that the European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS)...

FDA accepts filing of NDA for Lynparza for patients with metastatic castration-resistant prostate cancer . AstraZeneca + Merck Inc.

 Added 20 hours ago

AstraZeneca and MSD Inc.,announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review...

European Commission approval for Mayzent to treat secondary progressive multiple sclerosis.- Novartis

 Added 20 hours ago

Novartis announced the European Commission (EC) has approved Mayzent (siponimod) for the treatment of adult patients with secondary progressive multiple...

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

 Added 1 day ago

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

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.

 Added 1 day ago

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

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

 Added 2 days ago

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

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

 Added 2 days ago

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

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