September 22, 2025

FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay

3 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Abnormality of mitochondrial metabolism, Accelerated, Approved, Elamipretide, Forzinity, Infrequent, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval

CDC Advisors Shift COVID-19 Vaccine Guidance to Individual Decision-Making

3 weeks ago talkbio0Tagged ACIP, Centers for Disease Control and Prevention (U.S.), Consultation, COVID19 (disease), individual choice, Provider, Recommendation, Vaccines

CDC; COVID-19 vaccine; vaccine recommendation; individual choice; ACIP; provider consultation

FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome

3 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Clinical Trials, Elamipretide, Forzinity, Infrequent, Mitochondrial Diseases, Pediatric Disorder, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial

Big Pharma-Backed MapLight Plots IPO to Advance Neuro Pipeline

3 weeks ago talkbio0Tagged Alzheimer 's disease psychosis, Biological Factors, Clinical Trials, IPO, MapLight Therapeutics, Morgan Stanley, Muscarinic Agonists, neuro pipeline, Schizophrenia, Series D financing

MapLight Therapeutics; IPO; neuro pipeline; Alzheimer’s disease psychosis; schizophrenia; M1/M4 muscarinic agonist; Series D financing; Morgan Stanley; biopharmaceutical; clinical trials

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

3 weeks ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach

3 weeks ago talkbio0Tagged Approved, Biosimilars, checkpoint inhibitors, Immunotherapy for cancer, Keytruda, Keytruda Qlex, Merck, patent expiration, Solid Neoplasm, Subcutaneous Injections, United States Food and Drug Administration

Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy

Recent News: Gain Peace of Mind with the Lentiviral Experts

3 weeks ago talkbio0Tagged advanced manufacturing, Biological Factors, CAR-T therapy, gene therapy, Growth, immuno-oncology, lentiviral vectors, Market, regulatory approval

lentiviral vectors; CAR-T therapy; gene therapy; biologics; immuno-oncology; market growth; advanced manufacturing; regulatory approval