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 U.S. Food and Drug Administration (FDA) cleared Haifa, Israel-based Pluristem Therapeutics’ Investigational New Drug (IND) application for PLX-R18 to treat acute radiation syndrome (ARS).
Novartis released new information that showed siponimod consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations.
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.
Shares of Rigel Pharmaceuticals shot up about 40 percent during Thursday trading due primarily to an error on the company’s website that claimed its drug candidate Tavalisse had gained approval from the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental Biologic License Application (sBLA) for Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) under specific circumstances.
The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients.This marks the third HIV approval for the company.
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for a type of colorectal cancer.
Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma.
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostate cancer treatment.