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China’s drug regulator has expanded treatment options for patients with rare, genetically driven cancers by approving Zai Lab Limited’s AUGTYRO™ (repotrectinib) for adult patients with…
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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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