Traferox Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval ...
Brian Sullivan, CEO of Plymouth-based Celcuity, is convinced his biotech startup will soon provide the new standard of care for tens of thousands of breast cancer patients. Last week, Celcuity won ...
8don MSNOpinion
FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation
At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...
Celcuity wins FDA approval for REVTORPYK in HR+/HER2- breast cancer; outlook tempered by phase 3 data, competition & launch ...
Although Secretary Kennedy promised it months ago, a new rule for the Generally Recognized as Safe process is scheduled to be ...
Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...
As the agency considers seven unapproved peptides, Michael A. Sekeres traces the origins of the FDA’s authority.
Buying weight-loss drugs online carries risks. Many are unapproved GLP-1 copycats that lack FDA safety testing.
The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard of care for patients with breast cancer. The regulator is allowing ...
The FDA has approved Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor for adults with high cholesterol.The ...
Discusses FDA Approval of REVTORPYK for Advanced HR+/HER2- Breast Cancer and Commercial Launch Plans July 14, 2026 5:30 PM ...
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