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Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated…
AstraZeneca’s has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung…
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Almirall licenses an anti-IL-21 monoclonal antibody from Novo Nordisk to develop it as a…
Almirall S.A. announced that it has entered into an exclusive license agreement with Novo Nordisk for rights to the IL-21 blocking monoclonal antibody NN-8828. Under the agreement,…
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GSK completes acquisition of Aiolos Bio
GSK plc announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients…
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FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the…
Takeda announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and…
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AbbVie Completes Acquisition of ImmunoGen
AbbVie announced that it has completed its acquisition of ImmunoGen. With the completion of the acquisition, ImmunoGen is now part of AbbVie.
"Together with ImmunoGen, we have the…
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GSK receives US FDA Fast Track designation for bepirovirsen in chronic hepatitis B
GSK plc announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the…
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Saama and Pfizer Expand Agreement to Integrate AI-Driven Data Solutions Across R&D Portfolio
Saama, a provider of AI-based solutions that accelerate clinical development and commercialization, announced a newly expanded, multi-year agreement with global biopharmaceutical leader…
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GSK’s RSV vaccine, Arexvy, accepted under Priority Review in US for the prevention of RSV disease in…
GSK plc announced that the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial…
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Novo Nordisk to acquire three fill-finish sites from Novo Holdings A/S in connection with the…
Novo Nordisk announced that the company has agreed to acquire three fill-finish sites from Novo Holdings A/S (Novo Holdings) in connection with a transaction where Novo Holdings has…
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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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