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George Medicines Gains FDA Nod for Hypertension Triple-Combo Pill FDA George Medicines'Widaplik, a first-of-its-kind triple-combination pill for hypertension, gains FDA approval for initial treatment. U.S. launch planned in Q4 2025.
Avidity's FSHD Drug Gains FDA Support Avidity Avidity Biosciences' siRNA therapy delpacibart braxlosiran shows promise in treating FSHD, gaining FDA support for accelerated approval and advancing to Phase III trials.
FDA Roundtable Targets Faster Cell and Gene Therapy Approvals HHS FDA leaders and top scientists met to discuss cutting red tape in cell and gene therapy approvals. The roundtable emphasized faster innovation, global competition, and regulatory reform amid looming budget cuts.
CDC Official Resigns as COVID Vaccine Guidance Shifts Vaccine The CDC's senior COVID vaccine expert Dr. Lakshmi Panagiotakopoulos has resigned amid shifting U.S. vaccine recommendations. Recent policy changes, including removed guidance for children, have sparked debate among health officials.
Bayer’s Nubeqa Gains FDA Expansion for Broader Prostate Cancer Use Bayer Bayer secures FDA approval to expand Nubeqa's use for all metastatic castration-sensitive prostate cancer patients, including those unable to tolerate chemotherapy, strengthening its position in the prostate cancer treatment market.
Kura and Kyowa's Ziftomenib Shows 23% Remission in AML Trial ASCO Kura Oncology and Kyowa Kirin announced a 23% remission rate in their phase 2 trial of oral leukemia drug ziftomenib for relapsed/refractory NPM1-mutant AML, with FDA approval under review and phase 3 trials planned.
FDA Rejects Elamipretide Despite Support, Stealth Biotherapeutics Plans Resubmission FDA Stealth Biotherapeutics faces FDA rejection for elamipretide, a treatment for Barth syndrome, despite a favorable advisory vote. The company plans a resubmission amid layoffs and calls for swift regulatory action.
Four Biotechs Face Challenges Amid U.S. COVID-19 Vaccine Funding Cuts FDA U.S. COVID-19 vaccine biotechs face funding cuts, regulatory changes, and operational challenges. Learn how Vaxart, Novavax, GeoVax, and CastleVax navigate this uncertain landscape impacting future pandemic preparedness.
FDA Halts Rocket’s Gene Therapy Trial After Fatality FDA Rocket Pharmaceuticals faces an FDA clinical hold on its gene therapy trial for Danon disease following a patient death. The company is reassessing its approach and extending its financial runway into 2027.
GSK Gains Ground in COPD Market with Nucala GSK GSK’s Nucala has received FDA approval as an add-on treatment for eosinophilic COPD, positioning it against Dupixent. Backed by strong trial results, GSK targets $669M in peak annual sales for the new indication.

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