concerns – Talk Bio

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

3 weeks ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys

2 months ago talkbio0Tagged approval status, CBER, concerns, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Safety, Scientific Study, shipment, United States Food and Drug Administration

Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status

Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

2 months ago talkbio0Tagged concerns, ELEVIDYS, gene therapy, halt, Muscular Dystrophy, Duchenne, patient deaths, Roche (company), Safety, shipment, United States Food and Drug Administration

Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths

Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure

2 months ago talkbio0Tagged concerns, DMD, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Safety, shipment, Suspensions, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

2 months ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

2 months ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution

2 months ago talkbio0Tagged Adverse event, chikungunya vaccine, concerns, Elderly (population group), European Medicines Agency, Ixchiq, label extension, Safety, Valneva

Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

3 months ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference

FDA, CDC call for pause of chikungunya shot rollout in older adults

4 months ago talkbio0Tagged Adverse event, Centers for Disease Control and Prevention (U.S.), Chikungunya Fever, concerns, Elderly (population group), Ixchiq vaccine, pause recommendation, Safety, United States Food and Drug Administration

Ixchiq vaccine, chikungunya, safety concerns, older adults, FDA, CDC, pause recommendation, adverse events

MacroGenics Discontinues Development of Vobra Duo ADC After Phase 2 Prostate Cancer Trial Results

6 months ago talkbio0Tagged Antibody-Drug Conjugates, CD276 gene, concerns, development aspects, discontinued, Larix, MacroGenics, Malignant neoplasm of prostate, Safety, vobra

MacroGenics, vobra duo, antibody-drug conjugate, B7-H3, prostate cancer, TAMARACK trial, discontinued development, safety concerns