FDA Grants Early Access to Breakthrough Pancreatic Cancer Drug
The US FDA approves expanded access to daraxonrasib, an innovative pancreatic cancer drug, offering new hope for patients facing one of the deadliest forms of cancer.
FDA
Federal Appeals Court Limits Nationwide Access to Abortion Pill by Mail
A US federal appeals court rules to temporarily halt FDA rules allowing mail-order access to the abortion drug mifepristone, significantly impacting reproductive healthcare access nationwide.
US appeals court blocks FDA rule allowing mail-order abortion pills
A US federal appeals court issued a temporary order blocking the FDA’s rule allowing women to obtain the abortion drug mifepristone by mail, a ruling that will impact drug accessibility nationwide.
FDA Grants Early Access to Promising Pancreatic Cancer Drug Daraxonrasib
The FDA approves an expanded access program for daraxonrasib, an innovative pancreatic cancer drug that showed promising results in clinical trials, offering new hope for patients with one of the most challenging cancers.
FDA Grants Expanded Early Access to Pancreatic Cancer Drug Daraxonrasib
The U.S. FDA approves expanded early access for the experimental pancreatic cancer drug daraxonrasib, offering new hope for late-stage patients.
FDA Plans to Accelerate Clinical Trial Approvals Using AI and Real-Time Data
The US FDA has announced plans to introduce AI and real-time data technology to accelerate drug clinical trial approvals, marking a fundamental shift in drug development regulatory processes.
FDA Approves World's First Gene Therapy for Genetic Hearing Loss in Record 61 Days
The FDA has approved Regeneron’s Otarmeni, the world’s first dual AAV vector-based gene therapy for severe-to-profound sensorineural hearing loss caused by OTOF gene mutations, with 80% of patients showing hearing improvement in clinical trials.