U.S. Food and Drug Administration– tag –
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Insilico Medicine’s AI-Driven Pan-TEAD Inhibitor ISM6331 Receives FDA Fast Track Designation for Advanced Mesothelioma, Accelerating Development
Insilico Medicine Press Release USA Overview Insilico Medicine announced that its AI-driven pan-TEAD inhibitor, ISM6331, developed using the Chemistry42 platform, received Fast Track Designation from the FDA for advanced malignant pleura... -
First PROTAC Approval Validates Targeted Protein Degradation as a Breakthrough Modality for Cancer Treatment
Converge Bio Unknown Overview The FDA approval of vepdegestrant, developed by Arvinas and Pfizer, signifies a major milestone for targeted protein degradation (TPD). This first-in-class PROTAC, approved for ER+/HER2-, ESR1-mutated advanc... -
FDA Approves First PROTAC Vepdegestrant (ARV-471) for ER+/HER2- Breast Cancer, Ushering in a New Era of Targeted Protein Degradation
Journal of Medicinal Chemistry - ACS Publications USA Overview On May 1, 2026, the FDA approved vepdegestrant (ARV-471; Veppanu), making it the first heterobifunctional PROTAC protein degrader approved for clinical practice. Indicated fo... -
Eli Lilly’s Triple Agonist Retatrutide Achieves 21-23% Weight Loss in Diabetic and CVD Patients Over 80 Weeks, Nears FDA Submission
BioPharma Dive USA Overview Eli Lilly is preparing to seek FDA approval for its obesity drug retatrutide, a triple agonist targeting GLP-1, GIP, and glucagon receptors. New data from the Triumph-2 and Triumph-3 studies showed average bod... -
FDA Approves Sanofi’s Subcutaneous Isatuximab (Sarclisa Escena) for Multiple Myeloma, Enhancing Patient Convenience
Drugs.com USA Overview The U.S. FDA has approved Sanofi's subcutaneous formulation, Sarclisa Escena (isatuximab-irfc), for multiple myeloma, significantly improving administration convenience for patients. This new formulation reduces tr... -
FDA Approves Celcuity’s Breakthrough Gedatolisib for Advanced Breast Cancer with Priority Review Designation
Life Science Daily News USA Overview The FDA approved Celcuity's first-in-class PI3K/AKT/mTOR pathway inhibitor, gedatolisib, for advanced breast cancer on its PDUFA date of July 17, 2026. This approval, following Priority Review and Bre... -
Eli Lilly Acquires AtaiBeckley to Accelerate Phase III Development of BPL-003 for Treatment-Resistant Depression and Mental Health
Eli Lilly and Company USA Overview Eli Lilly announced the acquisition of AtaiBeckley to accelerate the development of therapies for treatment-resistant depression (TRD) and other mental health conditions. AtaiBeckley's lead candidate, B... -
How Gene Therapies Get to Patients Faster: Liv Hospital Explores FDA’s Expedited Pathways
Liv Hospital Turkey Overview Liv Hospital has published a comprehensive article clarifying the U.S. FDA's expedited approval pathways for gene therapies, focusing on Breakthrough Therapy Designation and Accelerated Approval. These crucia... -
FDA Seeks Input on Psychedelic Drug Therapeutic Use: Exploring Psilocybin and MDMA for Depression and PTSD
RAPS USA Overview The U.S. FDA is soliciting public input on the potential therapeutic uses of psychedelic drugs, specifically psilocybin for depression and MDMA-assisted therapy for PTSD. While the FDA granted Breakthrough Therapy Desig... -
Samsung Biologics Acquires PolyPeptide in All-Cash Offer: Accelerating Multi-Modality Strategy and Global Network Expansion
PR Newswire South Korea Overview Samsung Biologics announced an all-cash offer to acquire PolyPeptide, accelerating its multi-modality strategy and expanding its global manufacturing network across the U.S., Europe, and India. This acqui...
