FDA
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
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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.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
By merging with New Haven’s SPAC Thimble Point Acquisition Corp., Pear will be valued at $1.6 billion.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
The FDA said that arimoclomol, which has been studied and submitted for NPC indication, needs further data to support its use in this rare, progressive genetic disorder.
New data shows Zolgensma, Novartis’ gene therapy for spinal muscular atrophy, has the potential to be used presymptomatically in juveniles.
Three other drug contenders that work similarly to Biogen’s drug are currently in clinical trials and expecting data relatively soon.
The U.S. FDA approved Ayvakit for the treatment of adult patients with advanced sytematic mastocytosis (SM), advanced SM, and mast cell leukemia.
Both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI.
In an eight page letter to U.S. DOH and Human Services Secretary Xavier Becerra, Public Citizen said Woodcock and other FDA officials should resign.
The StrataGraft is designed to help heal patients who have received thermal burns that would ultimately require a skin graft. Here’s everything about it.