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Approvals, Safety & REMS
FDA/EMA decisions, boxed warnings, pharmacovigilance, and label changes.
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Latest in Approvals, Safety & REMS
Biogen Publishes Phase 3 Pediatric EMPAVELI Data Showing Reduction in Proteinuria and Stabilized Kidney Function in Adolescents with C3g or Primary IC-MPGN
3+ day, 4+ hour ago (519+ words) Biogen published results from a prespecified adolescent subgroup analysis of the Phase 3 VALIANT study evaluating EMPAVELI (pegcetacoplan) in the Clinical Journal of the American Society of Nephrology......
ARO-C3 Market: Advancing Complement-Targeted Therapies for Kidney Diseases
17+ hour, 20+ min ago (539+ words) The ARO-C3 Market is emerging as an area of interest as the investigational RNA interference therapy progresses through clinical…Continue reading on Medium » ARO-C3 Market: Advancing Complement-Targeted Therapies for Kidney Diseases The ARO-C3 Market is emerging as an area of…...
Health Canada Authorizes Pfizer and BioNTech's Omicron XFG-Adapted COVID-19 Vaccine
3+ day, 12+ hour ago (297+ words) 2026-2027 COVID-19 vaccine formula targets the XFG variant, in line with Public Health recommendations to more closely match contemporary circulating variants The vaccine will be available through various distribution channels in the coming days and weeks KIRKLAND, QC, Sept. 17, 2026 /CNW/ -- Pfizer…...
Da Vinci SP gets expanded Europe indication
4+ day, 7+ hour ago (18+ words) vohnetwork.com Approval expands access to less invasive transvaginal procedures across Europe...
FDA grants priority review to Enspryng for MOGAD treatment
1+ week, 2+ day 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…...
Pills are keeping abortion accessible even where it's banned. A court is considering restrictions
1+ week, 4+ day 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…...
Federal appeals court to hear arguments in case on access to mail-order abortion pill mifepristone
1+ week, 4+ day 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…...
US Abortion Pill | Ap | rutlandherald.com
1+ week, 4+ day 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…...
US Appeals Court Affirms Vertex’s Fertility Service Coverage Plan Violates Anti-Kickback Statute
1+ week, 4+ day ago (26+ words) GenomeWeb US Appeals Court Affirms Vertexâs Fertility Service Coverage Plan Violates Anti-Kickback Statute...
Birth Control Implant Lawsuit 2026: Full Settlement Guide
1+ week, 6+ day 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…...