Approvals, Safety & REMS

1+ day, 13+ hour ago   (289+ words) The FDA granted priority review to a supplemental biologics license application for Enspryng for myelin oligodendrocyte glycoprotein antibody-associated disease, according to a press release from Roche. As Healio previously reported, the IL-6 inhibitor, which is approved for treating neuromyelitis optica spectrum…...

3+ day, 18+ hour ago   (882+ words) A panel of federal judges is set to hear arguments Wednesday over whether prescribing rules should be tightened for a key drug used in the most common abortion method in the United States, one of several ongoing efforts to restrict…...

3+ day, 14+ hour ago   (511+ words) The FDA permanently lifted in-person restrictions for the drug in 2023. A federal appeals court in Louisiana could decide whether patients in the U.S. can continue to access the abortion drug mifepristone by mail and at pharmacies. The U.S. 5th Circuit Court of Appeals…...

3+ day, 18+ hour ago   (148+ words) US Abortion Pill Rutland Herald FILE - Bottles of abortion pills mifepristone, left, and misoprostol, right, are displayed at a clinic in Des Moines, Iowa, Sept. 22, 2010. Pills are keeping abortion accessible even where it's banned. A court is considering restrictions Louisiana…...

4+ day, 9+ hour ago   (26+ words) GenomeWeb US Appeals Court Affirms Vertex’s Fertility Service Coverage Plan Violates Anti-Kickback Statute...

5+ day, 18+ hour ago   (1672+ words) The birth control implant lawsuit is gaining serious momentum in 2026. Thousands of women report severe injuries from devices like Nexplanon. If you suffered complications, you may qualify for compensation. Manufacturers Organon and Merck face mounting legal pressure. Reports of implant…...

1+ week, 4+ day ago   (417+ words) Heat index in the lower 100s for counties along the Michigan-Indiana state line. Hydrate, rest breaks, and sunscreen if outside long. WASHINGTON (TNND) — A federal judge paused a lawsuit brought by Texas and Florida that seeks to revoke the Food and…...

1+ week, 4+ day ago   (525+ words) WASHINGTON (OSV News) — A federal judge paused a lawsuit by Texas and Florida seeking to revoke the Food and Drug Administration’s approval of mifepristone, likely until after November’s midterm elections. The Aug. 30 ruling by U.S. Chief District Judge Reed…...

1+ week, 4+ day ago   (431+ words) The Republican attorneys general of Florida and Texas filed a lawsuit against the FDA last December seeking to permanently revoke the agency’s initial approval of mifepristone from 2000, along with subsequent decisions over the years that eased access for patients. Florida…...

1+ week, 4+ day ago   (71+ words) The Washington Post He wrote that grant solicitations for changes to funding reference public health studies that appear not to exist or do not support what they are cited for. A judge criticized the Department of Health and Human Services…...