Drug News

Added 23 hours 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 23 hours 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 23 hours 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 1 day 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 1 day 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 1 day 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 2 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...

Added 2 days ago Drug news

New EMA ruling on use of antibiotic vancomycin.

The European Medicines Agency (EMA) has recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in...

Added 2 days ago Drug news

FDA accepts BLA for tildrakizumab, a proposed treatment for psoriasis.- Sun Pharma.

Sun Pharmaceutical Industries Ltd announces the FDA acceptance of the Biologics License Application (BLA) for tildrakizumab. The FDA filing acceptance...

Added 2 days ago Drug news

Pfizer and Astellas discontinue ENDEAR study of Xtandi (enzalutamide)for the treatment of triple-negative breast cancer.

Astellas has announced a joint decision with Pfizer to discontinue the planned ENDEAR trial comparing Xtandi (enzalutamide) in combination with...

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