United States Food and Drug Administration – Page 10

Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death

2 months ago talkbio0Tagged Clinical Trials, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient safety, Therapeutic immunosuppression, Unable to walk (finding), United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; Elevidys; acute liver failure; non-ambulatory patients; FDA; clinical trial pause; immunosuppression; patient safety

Moderna Wins Expanded FDA Approval for RSV Vaccine in At-Risk Younger Adults

2 months ago talkbio0Tagged Adult, Approved, At-Risk, chronic health conditions, expanded label, Moderna, mRESVIA, RSV vaccine, United States Food and Drug Administration

Moderna; RSV vaccine; FDA approval; mRESVIA; at-risk adults; 18 to 59 years; expanded label; chronic health conditions

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

2 months ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

FDA Launches AI Tool to Accelerate and Transform Drug Review Processes

2 months ago talkbio0Tagged AI tool, application assessment, Automation, drug review, Elsa, Generative AI, regulatory science, United States Food and Drug Administration

FDA; AI tool; drug review; rapid review; generative AI; regulatory science; Elsa; automation; application assessment

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

2 months ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor

FDA Leaders Anticipate Imminent Drug Approval Decisions

2 months ago talkbio0Tagged approvals, Drug Approval, Leadership, PDUFA, regulatory decision, United States Food and Drug Administration

FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership

FDA Reinstates Generic Drug Policy Group After April Firings

2 months ago talkbio0Tagged Administrative action, Departure - action, development aspects, drug price, Generic Drugs, layoffs, Office, Policy, reinstatement, Transection (procedure), United States Food and Drug Administration

FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave

Merck Wins FDA Approval for RSV Antibody Drug, Intensifying Market Competition

2 months ago talkbio0Tagged Approved, AstraZeneca, competition, Enflonsia, Infant, Market, Merck, Monoclonal Antibodies, Respiratory syncytial virus, sanofi, United States Food and Drug Administration

Merck; FDA approval; RSV; monoclonal antibody; infants; Enflonsia; competitive market; Sanofi; AstraZeneca

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

2 months ago talkbio0Tagged Biopharma, country-of-origin labeling, digital quality systems, forced labor compliance, green manufacturing, import rules, Manufacturing, regulatory, Serialization, Trump administration tariffs, United States Food and Drug Administration

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization

FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

2 months ago talkbio0Tagged Biktarvy, CD4 + T-cell, Clinical Trials, Gilead Sciences, GS-1720, GS-4182, HIV, Lenacapavir, Lymphocyte Count measurement, safety signal, Study on Hold, United States Food and Drug Administration

FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir