The KEYTRUDA regimen is the first and only PD-1 inhibitor-based treatment approved in the European Union for these patients Approval supported by data from the Phase 3 KEYNOTE-B96 trial in which the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free and overall survival compared to placebo plus paclitaxel, with or without bevacizumab Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab), in combi

Research published in Molecular Therapy Nucleic Acids demonstrates broad biodistribution and controlled PMP22 silencing, supporting advancement toward human trials Armatus Bio, a late-preclinical stage biotech innovator developing vectorized RNAi medicines in neuromuscular disorders, today announced the publication of foundational data in Molecular Therapy Nucleic Acids describing the safety and biodistribution impact of TVR110, a first-in-class and potential best-in-class vectorized microRNA i

Ray Therapeutics (RayTx), a clinical-stage biopharmaceutical company pioneering optogenetic therapies for those living with retinal degenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, RTx-015, for the treatment of retinitis pigmentosa (RP). "Receiving RMAT designation is a critical step as we move along the continuum of progress toward bringing hope to patients with a

Fast Track designation is one of the FDA’s expedited programs meant to facilitate development and expedite review of new drugs that have the potential to address an unmet medical need in the treatment of a serious or life-threatening condition April 01, 2026 -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced that the U.S. Food and Drug Administration

Novel Transdermal Curcumin Formulation Demonstrates Pain Reduction and Improved Quality of Life in Phase 1b Clinical Trial Study published in Frontiers in Pain Research reports significant reduction in knee pain with topical curcumin formulation April 1, 2026 -- Vascarta Inc. today announced the publication of results from a randomized, double-blind, placebo-controlled clinical trial evaluating VAS-101, the company's investigational topical/transdermal curcumin gel, for the treatment of knee pa

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for A2B543, an autologous CAR T-cell therapy designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. Fast Track is a pro

Adults taking Foundayo lost an average of 27 pounds on the highest dose in the ATTAIN-1 clinical trial1 Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-pay April 1, 2026 -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related me

Bezuclastinib NDA submitted under the FDA’s RTOR program based on positive results from Phase 3 PEAK trial; bezuclastinib previously granted Breakthrough Therapy Designation in GIST Bezuclastinib combination demonstrated 16.5 month mPFS and 46% ORR in imatinib-resistant GIST patients, dramatically improving upon the current standard of care April 01, 2026 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseas

April 01, 2026 -- Actinogen Medical Limited (ASX: ACW) announces that the first participant has been treated in the open-label extension (OLE) phase of the XanaMIA trial following completion of 36 weeks of treatment in the randomized phase. Open-label phase of up to 25 months duration, during which all participants will receive active Xanamem® 10 mg once daily, with no placebo control group Open to all former and current participants who have completed the randomized phase of the XanaMIA pivot

After Spinraza's FDA approval nearly a decade ago, Biogen's spinal muscular atrophy (SMA) drug captured rapid momentum and delivered blockbuster-level sales in just its second year on the market. While it's been a reliable revenue contributor ever since, rival meds from Roche and Novartis have taken away some of Spinraza's steam over the years. Now, Biogen is ready with its answer, as the FDA has approved the company's high-dose version of its SMA blockbuster. The new version features an "accel