Drug Approval – Talk Bio

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Junshi Biosciences Announces Phase 3 Win for IL-17A Drug JS005 in Psoriasis, Prepares China NDA Submission

1 week ago talkbio0Tagged Biosciences, China, clinical endpoints, Drug Approval, IL-17A monoclonal antibody, JS005, Junshi, Psoriasis

Junshi Biosciences; JS005; IL-17A monoclonal antibody; psoriasis; phase 3 trial; clinical endpoints; China drug approval

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

2 weeks ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, Translucent, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

4 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program

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

1 month 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

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

2 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

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

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

2 months ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma

FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin

2 months ago talkbio0Tagged Drug Approval, fee structure, Mediation, PDUFA VIII, regulatory policy, United States Food and Drug Administration, user fees

FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

3 months ago talkbio0Tagged Accelerated, Biopharma, CNPV, Drug Approval, national priorities, Priority Review, public health medicine (field), Review [Publication Type], United States Food and Drug Administration, unmet

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

3 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment