FDA
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
FEATURED STORIES
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) approved Shire’s Takhzyro (lanadelumab-flyo) injection to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. The drug was accepted while under priority review.
Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.
This week has several action dates by the U.S. Food and Drug Administration (FDA) for a range of indications, including acne, intra-abdominal infections, and rare liver diseases. Here’s a look.
There’s been another milestone in the history of biotech: The world’s first RNAi gene-silencing drug, Alnylam Pharmaceuticals’ Onpattro, got approved on August 10. That makes 2018 a landmark year. But another year—2014—may prove just as influential for the field and how it develops.
Shire plc snagged approval from the U.S. Food and Drug Administration for Takhzyro (lanadelumab-flyo), a prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics’ SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The U.S. Food and Drug Administration (FDA) gave Bristol-Myers Squibb’s Opdivo (nivolumab) approval for metastatic small cell lung cancer (SCLC) for patients whose cancer has progressed after platinum-based chemotherapy and at least one other type of therapy.