United States Food and Drug Administration – Page 24

FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders

5 months ago talkbio0Tagged Biological Factors, CBER, CDER, Cells, Drug Industry, gene therapy, George Tidmarsh, Makary, Marty, Prasad, regulatory harmonization, United States Food and Drug Administration

FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry

Lilly’s Mounjaro Matches Cardiovascular Benefit of Trulicity in Landmark Trial, Paving Way for Expanded Approval

5 months ago talkbio0Tagged Cardiovascular system, Diabetes Mellitus, Non-Insulin-Dependent, dulaglutide, eli lilly, expansion, Hemoglobin A1c measurement, MACE-3, Mortality Vital Statistics, Mounjaro, non-inferiority, outcomes, SURPASS-CVOT, Trulicity, United States Food and Drug Administration, Weight Loss

Mounjaro; tirzepatide; Eli Lilly; cardiovascular outcomes; type 2 diabetes; SURPASS-CVOT; Trulicity; dulaglutide; major adverse cardiovascular events (MACE-3); non-inferiority; A1C reduction; weight loss; mortality; FDA expansion

FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints

5 months ago talkbio0Tagged ALS, Amyotrophic Lateral Sclerosis, Application procedure, Clinical Trials, Coya Therapeutics, Indonesian language, resource shortage, United States Food and Drug Administration

FDA; Coya Therapeutics; IND application; ALS; clinical trial delay; COYA 302; resource shortage

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

5 months ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

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

5 months 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

5 months 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

5 months 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)

5 months ago talkbio0Tagged Access, 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