The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Journey Medical Corporation announced that the FDA has accepted the Company’s New Drug Application (“NDA”) for DFD-29 (Minocycline Hydrochloride ...
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The FDA approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced ...
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Cellipont Bioservices, a cell therapy Contract Development and Manufacturing Organization (CDMO), and Wugen, Inc., a clinical-stage biotechnology ...
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AstraZeneca entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel ...
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Charles River Laboratories International, Inc. announced an AAV9 production program agreement. As part of Charles River’s Cell and Gene Therapy (CGT) ...
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Santhera Pharmaceuticals announced the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States (U....
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Xcovery Holdings, Inc., announced that the FDA accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor ...
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Almac Sciences, a member of the Almac Group, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of ...
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Wednesday, March 13, 2024
Par Pharmaceutical is recalling one lot 57014 of Treprostinil Injection 20 mg/20mL (1 mg/mL) due to the potential for the presence of silicone ...
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Wednesday, March 13, 2024
IFM Therapeutics (IFM), a privately held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune ...
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Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA seeking approval of TREMFYA® (...
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Astellas Pharma US, Inc. announced that the U.S. FDA granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the ...
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The U.S. FDA announced it is requesting $7.2 billion as part of the President's fiscal year (FY) 2025 proposed budget.
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ADMA Biologics, Inc. announced the FDA’s approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend ...
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Celltrion USA announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to ...
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