Approvals
Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
After failing to gain market share under the umbrella of Valeant Pharmaceuticals, Addyi is getting a relaunch at half the price.
Array BioPharma, Inc. secured approval for its combination treatment for BRAF-mutant metastatic melanoma.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
Shares of Achaogen are down more than 19 percent in early trading after the FDA handed down a split approval and rejection of Zemdri (plazomicin) for the treatment of complicated urinary tract infections and bloodstream infection, respectively.
The FDA accepted Genentech’s New Drug Application (NDA) for baloxavir marboxil, a single-dose, oral flu treatment for people 12 years and older. It also granted it Priority Review.
In a first of its kind ruling, the U.S. Food and Drug Administration approved GW Pharmaceuticals’ Epidiolex, a cannabis-based treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Shares of Dr. Reddy’s Laboratories Ltd. are surging this morning after the FDA approved its generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction.
The U.S. Food and Drug Administration (FDA) granted Boston-based Albireo Pharma’s A4250 rare pediatric disease designation.
Following a meeting with the U.S. Food and Drug Administration Sage Therapeutics is seeing the goal line for potential expedited approval of its major depressive disorder (MDD) and postpartum depression (PPD) treatment, SAGE-217.
PRESS RELEASES