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Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study…
Johnson & Johnson announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2…
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Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share…
Novartis announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys AG, a Germany-based, global biopharmaceutical company developing…
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Regeneron Announces Formation of Regeneron Cell Medicines with the Acquisition of 2seventy bio…
Regeneron Pharmaceuticals, Inc. announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization…
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Gilead and Arcus Announce Amended Collaboration and Equity Investment
Gilead Sciences, Inc. and Arcus Biosciences, Inc. announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common…
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GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency for the…
GSK plc announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus…
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Takeda’s GAMMAGARD LIQUID Approved by FDA for Adults with Chronic Inflammatory Demyelinating…
Takeda announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and…
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Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for…
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Sanofi to acquire Inhibrx, Inc., adding potential best-in-class rare disease asset for Alpha-1…
Sanofi and Inhibrx, Inc. (“Inhibrx”), a publicly traded clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, have…
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Sandoz announces agreement to acquire CIMERLI business from Coherus, strengthening position in US…
Sandoz, the global leader in generic and biosimilar medicines, has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc.…
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FDA Grants Full Approval for BALVERSA to Treat Locally Advanced or Metastatic Bladder Cancer with…
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA (erdafitinib) for the treatment…
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European Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy…
Roche announced that the European Commission has granted marketing authorisation for Tecentriq SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for…
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FDA Approves Takeda’s HYQVIA as Maintenance Therapy in Adults with Chronic Inflammatory…
Takeda announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance…
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Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype
GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults…
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Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline
Merck, known as MSD outside of the United States and Canada, and Harpoon Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck,…
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Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to…
Johnson & Johnson announced it has entered into a definitive agreement to acquire Ambrx Biopharma, Inc., or Ambrx, a clinical-stage biopharmaceutical company with a proprietary…
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Boehringer Ingelheim and 3T Biosciences enter into a second partnership to develop next-generation…
Boehringer Ingelheim and 3T Biosciences (“3T”) announced they have entered into a new strategic collaboration and licensing agreement focused on discovering and developing…
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Beyfortus approved in China for the prevention of RSV disease in infants
AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory…
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MediLink Therapeutics Announces Worldwide Collaboration and License Agreement with Roche to develop…
MediLink Therapeutics ("MediLink"), announced that it has entered into a worldwide collaboration and license agreement with Roche on the development of a next-generation antibody-drug…
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European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the…
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI)…
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GSK enters exclusive license agreement with Hansoh for HS-20093
GSK plc and Hansoh Pharma, a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders,…
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