The FDA has slapped a warning letter on Sanofi’s Genzyme facility in Framingham, Massachusetts, after an inspection last summer uncovered issues around subpar manufacturing error investigations, inconsistent active pharmaceutical ingredient production, improper equipment and more. More: Sanofi API plant hit
read moreThe agency previously placed a hold on the company’s prescription-to-OTC study for erectile dysfunction med Cialis, citing issues with protocol design. More: Sanofi's consumer health arm Opella secures FDA green light to pursue OTC Cialis study Source: fierce
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Cell and Gene Therapy Catapult reveals significant growth in UK trials More: UK sees 70% increase in phase I advanced therapy clinical trials in 2024 Source: News
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Collaboration aims to enhance accessibility of medicines information More: Datapharm expands into US market through partnership with phactMI Source: News
read moreEli Lilly and Merck & Co. are partnering with Purdue University to launch the Young Institute Pharmaceutical Manufacturing Consortium aimed at pioneering new advances in how medicines are produced. More: Lilly, Merck team with Purdue University to pioneer new drug
read moreAstraZeneca and Daiichi Sankyo’s second antibody-drug conjugate, TROP2-directed Dato-Dxd, has crossed the U.S. regulatory finish line. More: Datroway, 2nd ADC from AstraZeneca-Daiichi collab, wins first FDA nod in breast cancer Source: fierce
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