PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus ...
Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation FDA acceptance starts the review process and sets ...
The FDA has accepted Stealth BioTherapeutics’ new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26. The timeline is surprising since the agency ...
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing ...
MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The health ministry has amended the NDCT Rules to cut approval timelines for new drug trials and testing by half, aiming to ...
LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced ...
10don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
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 ...
Centre amends NDCTR-2019 to ease rules for approval of new drugs & investigational new drugs: Gireesh Babu, New Delhi Friday, January 23, 2026, 08:00 Hrs [IST] The Union health mi ...
Researchers at Harvard Medical School developed a tool that uses artificial intelligence to accelerate drug discovery and development. The new technology, called PDGrapher, applies machine learning to ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results