U.S. Food and Drug Administration– tag –
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FDA Approval a TPD Turning Point? Maria Soloveychik Cautions Single Molecule Success Doesn’t Guarantee All Targets
Drug Discovery Online USA Overview Maria Soloveychik acknowledges the FDA approval of a bivalent degrader as a crucial 'proof point' for the Targeted Protein Degradation (TPD) field but warns that this single molecular success does not n... -
Oral GLP-1 Market Shift: Foundayo (orforglipron) Gains FDA Approval After Oral Wegovy, Demonstrating Dosing Convenience Advantage
GoodRx Health USA Overview The oral GLP-1 receptor agonist market sees a new entrant as Foundayo (orforglipron) received FDA approval on April 1, 2026, becoming the second oral GLP-1 therapy after oral Wegovy (semaglutide). Foundayo offe... -
FDA Approves Dato-DXd (Datroway) for Metastatic Triple-Negative Breast Cancer based on Phase III TROPION-Breast02 Trial
Cancer Network USA Overview The U.S. FDA has approved datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 immune check... -
EMD Serono’s Investigational Enpatoran Granted FDA Breakthrough Therapy Designation for Active Cutaneous Lupus
Lupus Foundation of America USA Overview EMD Serono's investigational drug enpatoran has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of systemic lupus erythematosus (SLE) with active cutaneous manifestat... -
Obesity Treatment Advances: Foundayo and Oral Wegovy Lead Oral GLP-1 Market, Retatrutide Shows Significant Weight Loss in Phase II
GoodRx Health USA Overview The obesity therapeutics market is rapidly evolving, with Foundayo (orforglipron) and oral Wegovy driving the oral GLP-1 segment. Foundayo, FDA-approved on April 1, 2026, offers the novel advantage of being tak... -
FDA Approves First-in-Class PROTAC Degrader Vepdegestrant for ESR1-Mutated Breast Cancer, Improving Progression-Free Survival by 43%
Dana-Farber Cancer Institute USA Overview The U.S. FDA has approved vepdegestrant (Veppanu), a first-in-class PROTAC (Proteolysis-Targeting Chimera) degrader, for patients with ER-positive, HER2-negative metastatic breast cancer harborin... -
Arrowhead’s Plozasiran Achieves Up to 81% Triglyceride Reduction in Severe Hypertriglyceridemia Phase 3, Pressuring Ionis
Fierce Biotech USA Overview Arrowhead Pharmaceuticals has reported robust Phase 3 SHASTA-3 and SHASTA-4 trial data for its siRNA therapeutic, plozasiran, in patients with severe hypertriglyceridemia (sHTG), putting pressure on competitor... -
siRNA Overcomes Gene Silencing Challenges with LNP and GalNAc Conjugation, Expanding Therapeutic Applications
Inside Therapeutics USA Overview Inside Therapeutics details how siRNA, while offering transformative gene silencing, is overcoming delivery challenges through lipid nanoparticles (LNP) and N-acetylgalactosamine (GalNAc) conjugation tech... -
Antibody-Drug Conjugates Evolve into Smart Chemotherapy, Datroway Gains FDA Approval for Metastatic Triple-Negative Breast Cancer
Karchem Consulting USA Overview Antibody-Drug Conjugates (ADCs) are evolving into next-generation 'smart chemotherapies' by integrating precise targeting with innovative linker-payload technologies. Novel drug classes like nucleic acid a... -
First Oral ER PROTAC Vepdegestrant Gains FDA Approval, Ushering New Era in Targeted Protein Degradation
MDPI Switzerland Overview The field of Targeted Protein Degradation (TPD) marks a significant milestone with the FDA approval of vepdegestrant (VEPPANU, ARV-471), the first oral estrogen receptor (ER) targeted PROTAC, co-developed by Arv...
