FDA
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
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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.
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.
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It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
If approved, Takeda said Maribavir would become the first and only treatment indicated for CMV infection in refractory patients.
Janux plans to use the funds raised from the IPO to submit four Investigational New Drug applications to the U.S. FDA in the first half of 2022.
CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.
Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA’s delay on its Biologics License Application.
Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
Two of Merck’s Phase III pediatric trials show 15-valent pneumococcal conjugate vaccine, V114, may be safe and effective in healthy children.
Eli Lilly’s SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.