United States Food and Drug Administration – Page 4

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

3 weeks ago talkbio0Tagged Clinical Trials, Drug Approval, Heterogeneity, IGYNTE, melanoma, Oncolytic Immunotherapy, Rejection, Replimune, RETINITIS PIGMENTOSA 1, scientist protest, United States Food and Drug Administration

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

3 weeks ago talkbio0Tagged Accelerated, Advanced Melanoma, Approved, Cancer Therapeutic Procedure, Complete, IGNYTE trial, nivolumab, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration, vusolimogene oderparepvec

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

Untangling Sarepta’s Gene Therapy Fallout and Trust Deficit

3 weeks ago talkbio0Tagged AAVrh74 vector, clinical holds, ELEVIDYS, gene therapy, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Translucent, United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Elevidys; Duchenne muscular dystrophy; limb-girdle muscular dystrophy; patient deaths; FDA; AAVrh74 vector; regulatory action; clinical holds; transparency

Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK

3 weeks ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA

FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia

3 weeks ago talkbio0Tagged aceclidine, Approved, Eye Drops, LENZ, Myopia, presbyopia, United States Food and Drug Administration, VIZZ

FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

3 weeks ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

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

3 weeks 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

3 weeks 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

3 weeks 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

3 weeks 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