The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...

Intelligent Bio Solutions Inc. (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a rapid and non-invasive drug testing method ...

FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the ...

The troriluzole clinical development program encompassed the first industry clinical trials to generate data showing therapeutic potential in patients with spinocerebellar ataxia (SCA), a rare genetic ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe ...

Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary ...