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BioNTech SE  announced today the completion of the acquisition of Biotheus (“Biotheus”), a clinical-stage biotechnology company dedicated to the discovery and development of novel…
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AstraZeneca’s Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer…
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Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of BRAFTOVI (encorafenib) in combination with cetuximab…
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The National Medical Products Administration (NMPA) in China has approved Sarclisa, in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd),…
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Merck, known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application…
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Pfizer Inc.announced positive results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil,…
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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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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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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, 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 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 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 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 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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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 (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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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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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 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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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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