Approvals
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.
Novartis will quickly roll Mayzent out to U.S. physicians. The Swiss pharma giant plans to make the drug available within one week of the FDA approval.
Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM.
The approval of Zulresso marks the first and only treatment for postpartum depression (PPD) approved by the U.S. Food and Drug Administration.
This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years.
It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Aerie Pharmaceuticals Rocklatan (netarsudil and latanoprost ophthalmic solution) to decrease elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension.
Medical device company receives second FDA clearance, adding blood flow monitoring technology to portfolio
PRESS RELEASES