FierceBiotech2d
FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...
Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...
FDA to pull common but ineffective cold medicine from market
The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
Atlanta Journal-Constitution4d
FDA proposes pulling decongestants from shelves over one ingredient
For some products, it is the only ingredient, the FDA said in a news release issued Thursday. Others contain oral phenylephrine and acetaminophen, dextromethorphan or another active ingredient.
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
dvm3603d
FDA approves renewal for canine chemotherapy-induced diarrhea treatment
Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...