FDA
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.
The medical device market was about $521.2 billion last year and is projected to hit $674.5 billion by 2022. Here’s a look at the top 10 medical device companies in the world this year.
The U.S. Food and Drug Administration (FDA) approved AbbVie and Roche’s combination of Venclexta in combination with Rituxan (rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion in patients who have received at least one previous therapy.
Ironwood Pharmaceuticals, headquartered in Cambridge, Massachusetts, announced the U.S. Food and Drug Administration (FDA) had granted its olinciguat (IW-1701) Orphan Drug Designation for sickle cell disease.
The U.S. Food and Drug Administration (FDA) approved Genentech’s Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).
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