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AbbVie and Neomorph Partner to Develop Molecular Glue Degraders for Oncology and Immunology
AbbVie and Neomorph, Inc. announced a collaboration and option-to-license agreement to develop novel molecular glue degraders for multiple targets across oncology and immunology.…
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FDA Approves SPRAVATO (esketamine) as First and Only Monotherapy for Treatment-Resistant Depression…
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO (esketamine) CIII nasal spray, making…
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FDA Approves Lilly’s Omvoh for Crohn’s Disease, Expanding IBD Treatment Options
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease…
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AbbVie and Simcere Zaiming Partner to Develop Trispecific Antibody for Multiple Myeloma
AbbVie and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500…
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Daiichi Sankyo Acquires IP Rights for Anti-TA-MUC1 Antibody DS-3939 from Glycotope
Daiichi Sankyo Company, Ltd announced that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody,…
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Solid Biosciences Receives FDA IND Clearance for Dual Route Gene Therapy in Friedreich’s Ataxia
Solid Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SGT-212 for the treatment of…
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GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives US FDA Breakthrough Therapy…
GSK plc announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC)…
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GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis…
GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on…
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China’s NMPA Approves VYLOY (zolbetuximab) for First-Line Treatment of Advanced Gastric or…
Astellas Pharma Inc. announced that China's National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and…
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Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously…
Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal…
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FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
GSK plc announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for…
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Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track…
The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years…
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Ipsen and Biomunex announce exclusive global licensing agreement for first-in-class MAIT cell…
Ipsen and Biomunex Pharmaceuticals announced an exclusive global licensing agreement for BMX-502. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T…
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Lilly’s Zepbound (tirzepatide) superior to Wegovy (semaglutide) in head-to-head trial showing…
Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound (tirzepatide) provided a 47% greater relative weight loss…
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Takeda Strengthens Oncology Pipeline with Elritercept through Licensing Agreement with Keros…
Takeda announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. to further develop, manufacture and commercialize elritercept worldwide outside…
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Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy…
Roche announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage biopharmaceutical company pioneering…
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Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide,…
Amneal Pharmaceuticals, Inc. announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug…
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Samsung Biologics signs manufacturing deal with European pharmaceutical company
Samsung Biologics announced a series of manufacturing deals with a Europe-based pharmaceutical company.
The disclosed deals, worth over USD 668 million combined, will run through…
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Datopotamab Deruxtecan BLA Submitted for Accelerated Approval in the U.S. for Advanced EGFR-Mutated…
AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of…
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QIAGEN collaborates with McGill University to advance microbiome research
QIAGEN announced a collaboration with the McGill University Centre for Microbiome Research to support microbiome research activities and outcomes.
The three-year partnership will…
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