Food and Drug Administration (FDA)
NEWS
Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration late Friday, marking it as the first such treatment to be approved in pill form.
Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.
The U.S. Food and Drug Administration approved Keytruda in combination with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma.
Erleada is an androgen receptor inhibitor approved for non-metastatic castration-resistant prostate cancer.
Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, has announced positive data from its ENCASE I* clinical trial.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC issued a press release to report the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of Tremfya for the treatment of adult patients with active psoriatic arthritis.
Law firm urges Zantac users to find out their rights against drug maker who knowingly sold potentially carcinogenic medication
Auris Medical Holding Ltd. announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® from the U.S. Food and Drug Administration and from the European Medicines Agency.
Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration has granted orphan drug designation for nomacopan for the treatment of bullous pemphigoid.
JOBS
IN THE PRESS