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.
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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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Sweden-based Sobi and Swiss-based Novimmune announced the U.S. approval of Gamifant (emapalumab-lzsg) to treat an ultra-rare disease in adults and children. Sobi’s U.S. offices are in Waltham, Mass.
YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US
Modus Therapeutics AB announces that the FDA has accepted its sevuparin IND for the treatment of SCD.
The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.
Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease.
According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer.
Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
The U.S. FDA approved Pfizer’s Lorbrena (lorlatinib) for ALK-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease hasn’t progressed on crizotinib and at least one other ALK inhibitor or for patients whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor.
Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.