FDA
FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
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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 FDA approved Dynavax’s Heplisav-B, it’s first new hepatitis B vaccine in the U.S. in more than 25 years.
CMV is a common and potentially serious viral infection in allogeneic HSCT recipients.
People diagnosed with the rare blood disorder known as Erdheim-Chester disease have a new treatment option.
EyeOP1 is an high-intensity focused ultrasound device that is the first non-invasive treatment for glaucoma in China.
Tianjin CanSino Biologics announced CFDA approval of its Ebola virus vaccine for China.
Alexion is set to secure even more revenue from its blockbuster drug Soliris, the most expensive drug in the world.
Big pharmas are having a good year so far in terms of FDA approvals.
A look at how the gene therapy approvals may end up confusing payers, lawmakers, and the general public at a time when the industry desperately needs clarity.
An advisory panel with the FDA gave a near unanimous support to Novo Nordisk’s diabetes drug semaglutide, a long-acting GLP-1 analogue.
Maybe timing is everything. On Aug. 28, 2017, Gilead acquired Kite for about $11.9B.