FDA
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
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After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
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.