The FDA’s surprise release of 200 complete response letters (CRLs) offered a rare glimpse into the inner workings of the agency’s decision-making—and the winding paths some drugs took to eventually reach the market. Among the disclosures were rejections for now-approved…
European Commission Approves TEVIMBRA® (Tislelizumab) with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma BeOne Medicines Ltd., a global biotechnology company dedicated to oncology innovation, today announced that the European Commission (EC) has granted marketing authorization for TEVIMBRA®…
Bayer Secures German Operations Until 2030 with New Agreement, Plans Structured Exit from Frankfurt Site In a significant development for its workforce and long-term operational strategy in Germany, Bayer AG has reached a landmark agreement with employee representatives on the…
Biogen and Stoke Present New Zorevunersen Data Supporting Phase 3 Dravet Syndrome Study Biogen and Stoke Therapeutics, Inc. (Nasdaq: STOK) today presented new data supporting the design and dosing strategy of the ongoing Phase 3 EMPEROR study of zorevunersen, an…
BeOne, a global oncology company, today announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC) not suitable for curative surgery…
Otsuka Pharmaceutical Launches POCARI SWEAT in India, Strengthening Global Nutraceutical Expansion Otsuka Pharmaceutical Co., Ltd. (Otsuka) has officially launched sales of its popular health drink, POCARI SWEAT, in India as of July. Known for its carefully balanced formula of ions…
Astellas Reports Preliminary U.S. Sales of IZERVAY™ Reach ¥15.9 Billion ($110 Million) in Q1 FY2025 Astellas Pharma , a leading global pharmaceutical company under the leadership of President and CEO Naoki Okamura, today announced preliminary sales figures for its recently…
The Longevity Revolution: Six Biotech Startups Transforming How We Age Armed with cutting-edge biological science, advanced computational tools, and deep-pocketed investors, a new wave of biotech startups is targeting what may be the next frontier in medicine: longevity. With approximately…
Trump Floats 200% Tariffs on Pharma Imports, Offers Industry One-Year Grace Period In a move that could significantly reshape the pharmaceutical supply chain and global drug trade, President Donald Trump announced Tuesday that imported pharmaceutical products could face tariffs of…
Supreme Court Halts Injunction, Allowing RFK Jr.’s HHS Workforce Cuts to Move Forward The U.S. Supreme Court on Tuesday issued a stay that permits the Trump administration to proceed with sweeping federal workforce reductions, including a controversial plan by Health…
AstraZeneca’s Alexion Taps JCR Pharmaceuticals for Gene Therapy Capsids in Deal Worth Up to $825M AstraZeneca’s rare disease unit, Alexion, is deepening its partnership with Japan-based JCR Pharmaceuticals through a new licensing deal that could be worth up to $825…
Nuclidium Secures $99M Series B to Advance Copper-Based Radiopharma Platform Swiss biotech Nuclidium has raised approximately $99 million in a Series B funding round to accelerate the development of its copper-based radiopharmaceutical platform. The round was led by Kurma Growth…
