United States Food and Drug Administration – Page 5

Bausch Health to Acquire DURECT and Breakthrough Liver Disease Candidate Larsucosterol for $63M Upfront

3 weeks ago talkbio0Tagged Acquisition, Bausch Health, Breakthrough Therapy, Dosage Forms, DURECT, epigenetic modulator, Hepatitis, Alcoholic, Larsucosterol, Liver diseases, milestone payments, United States Food and Drug Administration

Bausch Health; DURECT; larsucosterol; liver disease; alcoholic hepatitis; epigenetic modulator; FDA Breakthrough Therapy; acquisition; pharmaceutical; milestone payments

FDA Reverses Course, Allows Sarepta to Resume Duchenne Gene Therapy Shipments

4 weeks ago talkbio0Tagged ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Resumption, Safety, shipment, United States Food and Drug Administration

FDA; Sarepta Therapeutics; Duchenne muscular dystrophy; Elevidys; gene therapy; safety pause; shipment resumption

Apellis’ Empaveli Gains FDA Approval for Broad C3 Glomerulopathy Use, Setting Up Competition with Novartis’ Fabhalta

4 weeks ago talkbio0Tagged Apellis, Approved, C3 glomerulopathy, Empaveli, Fabhalta, Iptacopan, Kidney Diseases, membranoproliferative glomerulonephritis, Novartis, pegcetacoplan, Proteinuria, United States Food and Drug Administration

Apellis; Empaveli; FDA approval; C3 glomerulopathy; primary immune complex membranoproliferative glomerulonephritis; Novartis; Fabhalta; pegcetacoplan; iptacopan; proteinuria; kidney disease

DTC vs. DTP: Regulatory Uncertainty & Access Challenges Drive New Go-to-Market Models (2025 Update)

4 weeks ago talkbio0Tagged Access, Aortic Valve Insufficiency, Artificial Intelligence, Diphtheria-Tetanus-Pertussis Vaccine, Direct-to-Consumer, direct-to-patient, Ditiocarb, DTP, formulary restrictions, go-to-market models, OOP costs, pharmaceutical marketing, regulatory uncertainty, Rx abandonment, Telemedicine, United States Food and Drug Administration

DTC (Direct-to-Consumer); DTP (Direct-to-Patient); regulatory uncertainty; access challenges; pharmaceutical marketing; go-to-market models; FDA; Rx abandonment; formulary restrictions; OOP costs; telehealth; AI in marketing