Qualitative Concept – Page 3

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

1 month ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot

1 month ago talkbio0Tagged Approved, Gilead, Guidelines, HIV Prevention, Lenacapavir, Long-acting injectable, PREP gene, twice-yearly injection, United States Food and Drug Administration, World Health Organization, Yeztugo

Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines

FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid

1 month ago talkbio0Tagged Approved, Autoimmune Diseases, Bullous pemphigoid, Drugs, Orphan, dupilumab, Dupixent, Priority Review, Regeneron, sanofi, type 2 inflammation, United States Food and Drug Administration

Dupixent; Dupilumab; Sanofi; Regeneron; bullous pemphigoid; FDA approval; type 2 inflammation; autoimmune disease; priority review; orphan drug

FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot

1 month ago talkbio0Tagged Approved, Gilead Sciences, HIV Prevention, Lenacapavir, PREP gene, public health medicine (field), twice-yearly injection, United States Food and Drug Administration, Yeztugo

FDA approval; Gilead Sciences; Lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; public health

FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

1 month ago talkbio0Tagged Andembry, Angioedemas, Hereditary, Approved, dosing, factor XIIa, garadacimab-gxii, Inhibitor, SMPX gene, Subcutaneous Injections, Takeda, Takhzyro, United States Food and Drug Administration

Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection

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

1 month 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

GSK Licenses Experimental Shigella Vaccine to Bharat Biotech for Development and Distribution

1 month ago talkbio0Tagged Bharat, biotech, GMMA platform, low, Microbicides, middle-income countries, Resistance (Psychotherapeutic), Shigella Infections, Shigella Vaccines, SmithKline Beecham, vaccine licensing

GSK; Bharat Biotech; Shigella vaccine; altSonflex1-2-3; vaccine licensing; Shigellosis; GMMA platform; antimicrobial resistance; low and middle-income countries

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

1 month 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