Approved
Mineralys Phase 3 blood pressure pill data support potential FDA approval
United States Food and Drug Administration, Launch-HTN, Uncontrolled, Hypertensive disease, Approved
FDA Approves First Treatment for Macular Telangiectasia Type 2 (MacTel)
ENCELTO, revakinagene taroretcel-lwey, MacTel, FDA approval, encapsulated cell therapy, ciliary neurotrophic factor (CNTF)
Jazz Pharmaceuticals to Acquire Chimerix for $935 Million, Gaining Promising Brain Tumor Drug Dordaviprone
Jazz Pharmaceuticals, Chimerix, Acquisition, Dordaviprone, Brain tumor, H3 K27M-mutant diffuse glioma, FDA approval, Oncology pipeline
FDA Approves Label Changes for Indivior’s Sublocade, Enhancing Treatment Accessibility for Opioid Use Disorder
Sublocade, FDA approval, rapid initiation protocol, alternative injection sites, opioid use disorder treatment
FDA Approves Mirum’s Ctexli as First Treatment for Rare Lipid Disorder CTX
Ctexli, chenodiol, cerebrotendinous xanthomatosis (CTX), FDA approval, Mirum Pharmaceuticals, rare metabolic disorder, lipid storage disease, bile acid therapy
BridgeBio’s Attruby Gains FDA Approval, Challenging Pfizer’s Tafamidis in ATTR-CM Treatment
Attruby, acoramidis, BridgeBio, ATTR-CM, tafamidis, Pfizer, FDA approval, transthyretin stabilizer, cardiomyopathy
GSK’s Penmenvy Approved: New 5-in-1 Meningococcal Vaccine Enters U.S. Market
Penmenvy, GSK, meningococcal vaccine, FDA approval, 5-in-1 vaccine, MenABCWY, invasive meningococcal disease (IMD)
Bavarian Nordic’s Vimkunya Approved by FDA as First Chikungunya Vaccine for Ages 12 and Up
Vimkunya, chikungunya vaccine, Bavarian Nordic, FDA approval, virus-like particle vaccine, adolescents, travelers
FDA Approves Ono Pharmaceutical’s Romvimza for Rare Joint Tumor
Romvimza, tenosynovial giant cell tumor (TGCT), FDA approval, Ono Pharmaceutical, Deciphera acquisition, kinase inhibitor, rare cancer treatment
FDA Approves Ono’s Romvimza for Rare Joint Tumor, Challenging Daiichi Sankyo’s Turalio
Romvimza, vimseltinib, tenosynovial giant cell tumor (TGCT), Ono Pharmaceutical, FDA approval, Daiichi Sankyo, Turalio, CSF1 inhibitor, rare joint tumor