Drug News

Added 2 hours ago Drug news

Supplemental application for Tresiba (insulin degludec) in hypoglycaemia submitted to FDA- Novo Nordisk

Novo Nordisk has announced the submission of a supplemental application to the FDA for including data in the label for...

Added 2 hours ago Drug news

FDA expands approval of Zykadia (ceritinib) to include patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive- Novartis

The FDA has approved the expanded use of Zykadia (ceritinib), from Novartis, to include the first-line treatment of patients with...

Added 1 day ago Drug news

Oncologic Drugs Advisory Committee recommends Endari (l-glutamine) to treat sickle cell disease.-Emmaus Life Sciences Inc.

Emmaus Life Sciences Inc. announced that the Oncologic Drugs Advisory Committee of the FDA voted 10 to 3 that the...

Added 2 days ago Drug news

Sanofi announces CHMP recommendation for Insulin Lispro Sanofi (insulin lispro 100 Units/mL)a biosimilar for types 1 and 2 diabetes.

Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted...

Added 2 days ago Drug news

European Commission grants standard marketing approval for Fampyra (prolonged-release fampridine tablets) to improve walking for MS patients on the basis of ENHANCE study.-Biogen

The European Commission (EC) has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people...

Added 2 days ago Drug news

Successful Phase III trial of Roclatan (netarsudil/latanoprost ophthalmic solution) to treat glaucoma or ocular hypertension. - Aerie Pharmaceuticals Inc.

Aerie Pharmaceuticals, Inc. reported the successful primary efficacy results of the Company's 90-day Phase III Mercury 2" registration trial for...

Added 3 days ago Drug news

NEJM publishes Phase III trial of Epidiolex (cannabidiol) in children with Dravet syndrome. - GW Pharma

GW Pharmaceuticals plc announced that The New England Journal of Medicine has published results from a Phase III study of...

Added 3 days ago Drug news

Abilify (aripiprazole) embedded with a Proteus ingestible sensor is re-filed at FDA.- Otsuka + Proteus Digital Health

Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health announce that the FDA has acknowledged receipt of the New Drug Application...

Added 3 days ago Drug news

EMA widens scope of Zebinix (eslicarbazepine acetate) for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. - Bial + Eisai

The European Medicines Agency has approved the use of Zebinix (eslicarbazepine acetate) from Bial + Eisai for use as a...

Added 4 days ago Drug news

FDA accepts BLA from BMS for Opdivo (nivolumab) to treat hepatocellular carcinoma (liver cancer) after prior sorafenib therapy.

BMS has announced that the FDA accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of...

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