FDA
The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.
FDA inspectors found Alchymars failed to adequately maintain equipment used to make active pharmaceutical ingredients for the U.S. market. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.
Beren Therapeutics is seeking approval in Neimann-Pick disease type C, an application the FDA was set to decide on by August 17. The new target action date is November 17.
Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.
The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.
An FDA advisory committee recently voted against approving AstraZeneca’s oral SERD drug camizestrant for certain patients with advanced breast cancer. It is unclear when the new target action date for the drug will be.
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
After getting slapped with a surprise refuse-to-file letter signed by former CBER Director Vinay Prasad, Moderna’s flu vaccine application will now go before the FDA’s Vaccine advisory committee.