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Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company’s supplemental New Drug Application (sNDA) for…
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Roche has announced positive results from the Phase III evERA study evaluating giredestrant combined with everolimus in patients with estrogen receptor (ER)-positive, HER2-negative,…
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Moderna, Inc. has announced promising preliminary immunogenicity results for the 2025-2026 formula of its COVID-19 vaccine, mNEXSPIKE, which targets the SARS-CoV-2 LP.8.1 variant. Data…
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Eli Lilly and Company announced plans to construct a $6.5 billion state-of-the-art manufacturing facility at Generation Park in Houston, Texas. This new site will focus on producing…
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Servier, the independent international pharmaceutical group, announced that the European Commission (EC) has approved VORANIGO (vorasidenib) for treating predominantly non-enhancing…
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The U.S. Food and Drug Administration (FDA) has extended the target action date for its review of Sanofi’s new drug application (NDA) for tolebrutinib by three months, now set for…
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Minovia Therapeutics Ltd., a clinical-stage biotech focused on mitochondrial diseases and age-related conditions, has announced that the U.S. Food and Drug Administration (FDA) has…
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Novo Nordisk announced new findings from the REACH real-world study demonstrating that Ozempic (once-weekly injectable semaglutide) reduced the risk of major adverse cardiovascular…
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FUJIFILM Biotechnologies, a leading contract development and manufacturing organization (CDMO), announced a major expansion of its global partnership with immunology company argenx SE.…
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Roche announced that it has entered into a definitive agreement to acquire 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company developing innovative therapies for…
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