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Sanofi’s SAR446597 Granted FDA Fast Track for Geographic Atrophy in AMD
The U.S. Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy developed by Sanofi for the treatment of geographic…
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FDA Approves GSK’s Shingrix in Prefilled Syringe Format
GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix, the company’s vaccine for the prevention of shingles…
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Boehringer Ingelheim and LEO Pharma Partner to Commercialize and Develop SPEVIGO
Boehringer Ingelheim and LEO Pharma have entered an exclusive global license and transfer agreement to commercialize and further develop SPEVIGO (spesolimab), a monoclonal antibody…
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Merck to Acquire Verona Pharma, Adding First-in-Class COPD Drug Ohtuvayre to Pipeline
Merck, known as MSD outside the U.S. and Canada, announced that it will acquire Verona Pharma plc in a $10 billion deal, strengthening its presence in the respiratory disease space. The…
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AbbVie and IGI Ink Global Deal for First-in-Class Trispecific Antibody ISB 2001
AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI),announced an exclusive licensing agreement for IGI's lead…
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GSK Completes Acquisition of Efimosfermin to Combat Steatotic Liver Disease
GSK plc has finalized its acquisition of efimosfermin alfa from Boston Pharmaceuticals, a promising investigational therapy targeting steatotic liver disease (SLD). Efimosfermin is a…
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FDA Grants Priority Review for WINREVAIR Label Update Following ZENITH Trial Results
Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License…
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Lynozyfic (linvoseltamab-gcpt) Granted FDA Accelerated Approval for Relapsed/Refractory Multiple…
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients…
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Vetter Breaks Ground on New Clinical Site
Vetter, a leading, globally operating Contract Development and Manufacturing Organization (CDMO), celebrated the start of construction for its new clinical manufacturing site in Des…
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AbbVie to Acquire Capstan Therapeutics, Advancing Immunology Innovation
AbbVie and Capstan Therapeutics, Inc. announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19…
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Novartis Completes Acquisition of Regulus Therapeutics
Novartis has officially completed its acquisition of Regulus Therapeutics Inc., solidifying its strategic focus on advancing treatments for renal diseases. With the closing of the deal,…
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Gilead and Kymera Partner on Novel Oral CDK2 Degraders in Exclusive License Deal
Gilead Sciences, Inc. and Kymera Therapeutics, Inc. have announced an exclusive option and license agreement aimed at advancing a novel class of cancer treatments: molecular glue…
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FDA Approves Updated Label for Lilly’s Amyvid to Aid Alzheimer’s Diagnosis
Eli Lilly and Company announced that the U.S. FDA has approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. Amyvid is used for brain imaging to estimate…
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Novo Nordisk’s Ozempic Recommended by EU for Peripheral Arterial Disease in Type 2 Diabetes
Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to update the label of Ozempic…
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Datroway Approved in U.S. for Advanced EGFR-Mutated Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Datroway (datopotamab deruxtecan or Dato-DXd) for the treatment of adult patients with locally advanced…
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argenx Wins EU Approval for VYVGART SC to Treat CIDP
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the European Commission (EC) approved VYVGART…
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Yeztugo Becomes First FDA-Approved HIV Prevention with 6-Month Protection
Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir) as a pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV-1.…
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J&J Seeks FDA Approval of STELARA for Pediatric Crohn’s Disease
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of…
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Lilly to Acquire Verve Therapeutics for One-Time Cardiovascular Treatments
Eli Lilly and Company and Verve Therapeutics, Inc., a Boston-based clinical-stage company developing genetic medicines for cardiovascular disease, announced a definitive agreement for…
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Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Cancer Therapy
Teva Pharmaceutical Industries Ltd. and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that the companies, through their respective subsidiaries, have entered a strategic…
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