News

Outlook Therapeutics has received a setback in its efforts to bring an FDA-approved bevacizumab treatment for retinal disease to the U.S. market. The company announced that the U.S.…
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Samsung Bioepis has started direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe, marking a significant shift in the company’s regional strategy.…
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Eisai and Biogen have reached a new regulatory milestone in China with the acceptance of a Biologics License Application (BLA) for the subcutaneous formulation of LEQEMBI (lecanemab) by…
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Insilico Medicine, a global artificial intelligence (AI)–driven drug discovery company, has entered into a multi-year research and development collaboration with Servier, an independent…
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The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv), a therapy designed to delay…
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Takeda and Protagonist Therapeutics have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults…
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Arrowhead Pharmaceuticals has received regulatory clearance from Health Canada for REDEMPLO (plozasiran), marking a significant advance for patients living with familial chylomicronemia…
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Harbour BioMed has entered into a multi-year, global strategic collaboration and license agreement with Bristol Myers Squibb aimed at advancing the discovery and development of…
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GSK has received U.S. Food and Drug Administration approval for Exdensur (depemokimab-ulaa), a new add-on maintenance treatment for patients aged 12 years and older with severe asthma…
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Alnylam Pharmaceuticals has announced plans to significantly expand its manufacturing footprint in Norton, Massachusetts, committing an investment of $250 million to build what it says…
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Astellas Pharma and Pfizer have reported positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial, strengthening evidence that the combination of PADCEV™…
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Takeda Pharmaceutical Company has announced positive topline results from two pivotal Phase 3 clinical trials evaluating zasocitinib (TAK-279), a next-generation oral therapy for adults…
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Johnson & Johnson has secured U.S. Food and Drug Administration approval for RYBREVANT FASPRO™, marking a significant advance in the treatment of epidermal growth factor receptor…
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Beren Therapeutics P.B.C., the parent company of Mandos LLC, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to…
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Telix Pharmaceuticals has announced a strategic clinical collaboration with Varian, a Siemens Healthineers company and a global leader in radiation oncology, aimed at developing new…
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Zealand Pharma and OTR Therapeutics have entered into a multi-program strategic collaboration and licensing partnership aimed at discovering and developing a new generation of…
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Formation Bio and Lynk Pharmaceuticals have announced that Formation Bio has acquired worldwide rights—excluding Greater China—to LNK01006, a next-generation, central nervous system…
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China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast), marking the first new treatment for adults with progressive pulmonary fibrosis (PPF) in…
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Nanexa AB has entered into a new license and option agreement with Moderna Inc., marking a significant expansion of its long-acting injectable drug-delivery partnerships. The deal…
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China’s National Medical Products Administration (NMPA) has approved two innovative Sanofi therapies—Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired…
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