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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As the 2018 BIO International Convention wraps up in Boston today, it kicked off with a fireside chat with Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). The biosimilar was co-developed with Biocon.
Florida-based TherapeuticsMD is feeling a bit vindicated this morning after the U.S. Food and Drug Administration approved its vaginal pain medication.
Within the next six years, the multiple myeloma market is projected to be $37.5 billion – an incredible growth of $30 billion since 2015, when the market was valued at about $7.5 billion.
Pfizer’s Xalkori, the first drug approved in the United States for patients with ALK-positive and ROS1-positive non-small cell lung cancer, secured Breakthrough Therapy Designation from the U.S. Food and Drug Administration for two new indications.
Following the long holiday weekend, three pharma companies began the week with good news as the U.S. Food and Drug Administration awarded their therapies with Priority Review Status.
The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated. Here’s a look at two more FDA decisions coming up this week.
The U.S. Food and Drug Administration (FDA) gave BioMarin Pharmaceutical a thumbs-up for its Palynziq (pegvaliase-pqpz) to treat phenylketonuria (PKU).
Sun Pharma received approval from the U.S. Food and Drug Administration (FDA) for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer (mCRPC). Sun will launch the drug in the U.S. via a licensing deal with Churchill Pharmaceuticals, the original developer of the drug.
Dova Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved its Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.