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.
FEATURED STORIES
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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Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration approved the company’s generic version of the EpiPen Auto-Injector.
Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Onpattro (patisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is the first and only RNA interference (RNAi) therapeutic to ever be approved.
This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.
GW Pharmaceuticals has finally revealed the price of its cannabis-based epilepsy drug Epidiolex.
The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation.
Shares of Novo Nordisk are down about five percent this morning after the company reported an overall decline in sales during the second quarter of this year. Sales were particularly disappointing in North America.
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Shionogi, based in Osaka, Japan and Florham Park, New Jersey, announced that the U.S. Food and Drug Administration (FDA) approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who were about to have a medical procedure performed.