Phenomenon or Process – Page 3

Sarepta Therapeutics Halts Development of Vesleteplirsen, a Next-Generation Exon-Skipping Therapy for Duchenne Muscular Dystrophy

11 months ago talkbio0Tagged Duchenne, Exon-Skipping Therapy, Feedback - system communication, Landscapes, Muscular Dystrophy, Muscular Dystrophy, Duchenne, SRP-5051, United States Food and Drug Administration, Vesleteplirsen

Sarepta Therapeutics, Vesleteplirsen (SRP-5051), Duchenne Muscular Dystrophy (DMD), Exon-Skipping Therapy, FDA Feedback, Therapeutic Landscape

Novartis’ $2.9B MorphoSys Acquisition Hits Roadblock as Safety Concerns Delay Approval Filing

12 months ago talkbio0Tagged delayed approval, MorphoSys, Novartis, Safety, Signal

Novartis, MorphoSys, safety signal, delayed approval, biotech, pharmaceuticals

WuXi AppTec Faces Uncertainty Amid BIOSECURE Act, Yet Continues to Secure New Projects

12 months ago talkbio0Tagged AppTec, Biopharma, BIOSECURE, CDMOs, Contract agreement, Industry, Legislation, manufacturing organizations, National Security Concerns, Outsourcing, United States, WuXi

BIOSECURE Act, WuXi AppTec, Biotechnology Industry, U.S. Legislation, Contract Development and Manufacturing Organizations (CDMOs), Biopharma Outsourcing, National Security Concerns

WHO Approves First Mpox Diagnostic Test for Emergency Use: Expanding Global Access to Mpox Testing

1 year ago talkbio0Tagged Abbott Molecular, Alinity, Emergency Situation, Global Health Emergency, mpox, public health medicine (field), World Health Organization

WHO, mpox diagnostic test, emergency use, Abbott Molecular, Alinity m MPXV assay, global health emergency, public health efforts

FDA Authorizes Novavax’s Updated COVID-19 Vaccine for Emergency Use

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, JN.1, Novavax, protein-based vaccine, United States Food and Drug Administration, Vaccines, Variant

Novavax COVID-19 Vaccine, FDA Authorization, Emergency Use, Protein-Based Vaccine, JN.1 Variant

Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, JN.1, Novavax, protein-based vaccine, United States Food and Drug Administration, Vaccines, Variant

Novavax, COVID-19 vaccine, FDA, Emergency Use Authorization, protein-based vaccine, JN.1 variant

FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, Immunocompromised Host, Invivyd, Pemgarda, United States Food and Drug Administration, Variant

Invivyd, COVID-19, Pemgarda, Emergency Use Authorization, FDA, Immunocompromised, Variants

FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna for Enhanced Protection

1 year ago talkbio0Tagged Approved, authorization, COVID19 (disease), Emergency Situation, Guidelines, JN.1, KP.2, Lineage, Moderna, Pfizer, Pfizer/, RNA, Messenger, United States Food and Drug Administration, Vaccination, Vaccines, Variant

COVID-19 vaccines, FDA approval, mRNA vaccines, Pfizer, Moderna, updated vaccines, KP.2 variant, JN.1 lineage, emergency use authorization, vaccination guidelines.