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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
Vertex makes case for broader use of kidney disease candidate
1+ day, 2+ hour ago (11+ words) firstwordpharma.com...
License GONE: Abortion Pill Triggers Instant Shutdown
1+ day, 6+ hour ago (435+ words) Texas regulators stripped a doctor’s license after he prescribed an abortion-inducing drug, enforcing a state law that mandates revocation. Story Highlights The Texas Medical Board revoked Dr. William Evans’ license effective September 4, 2026. The board cited an inappropriate sexual relationship with…...
Vertex opens up larger kidney disease opportunity with mid-stage readout
1+ day, 6+ hour ago (679+ words) Vertex Pharmaceuticals’ inaxaplin reduced two key markers of kidney disease in a mid-stage trial, suggesting that the drug could be used in a broad population of patients as investors had hoped and prompting BMO Capital Markets analysts to describe the…...
Increased Ectopic-Pregnancy-Related Deaths Show Why FDA Must Reinstate Abortion Pill Safeguards
2+ day, 10+ hour ago (13+ words) National Review...
Biogen Publishes Phase 3 Pediatric EMPAVELI Data Showing Reduction in Proteinuria and Stabilized Kidney Function in Adolescents with C3g or Primary IC-MPGN
6+ day, 13+ 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
4+ day, 2+ hour 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
6+ day, 21+ 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
1+ week, 16+ 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, 5+ 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
2+ week, 17+ 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…...