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Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO (vedolizumab) for…
Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC)…
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Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in…
Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for…
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Novo Nordisk acquires Embark Biotech, including its lead asset targeting obesity and other…
Embark Laboratories announced that Novo Nordisk has acquired Embark Biotech, including its lead metabolic program, and has entered a three-year research and development collaboration to…
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Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to…
Roche announced that Tecentriq SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. It will be provided by the…
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FDA Approves Veklury (Remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment…
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose…
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LYNPARZA (olaparib)Plus Abiraterone and Prednisolone Approved in Japan for the Treatment of…
AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced that LYNPARZA in combination with abiraterone and prednisolone (abi/pred) has been approved in…
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FDA Grants Priority Review for XTANDI in Non-Metastatic Castration-Sensitive Prostate Cancer with…
Pfizer Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies’ supplemental New Drug…
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FDA Approves ABRYSVO, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in…
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF)…
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Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating…
Exelixis, Inc. and Ipsen announced that the global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in…
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CARsgen Collaborates with Moderna to Evaluate CT041 in Combination with an mRNA Cancer Vaccine
CARsgen Therapeutics Holdings Limited, a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that CARsgen and…
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Regeneron to Acquire Decibel Therapeutics, Strengthening Gene Therapy and Hearing Loss Programs
Regeneron Pharmaceuticals, Inc. and Decibel Therapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and…
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GenScript Expands Peptide Production Capabilities to Include Neoantigen Peptides and APIs
GenScript Biotech Corporation, the world's leading provider of life-science research tools and services, has ramped up production of complex and modified peptides at its…
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Astex Expands Drug Discovery Collaboration With MSD
Astex Pharmaceuticals (UK), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous…
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FDA Approves Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and…
Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now…
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AbbVie and Calibr Expand Strategic Collaboration to Advance Several Preclinical and Early-stage…
AbbVie and Calibr announced an expanded strategic collaboration to advance several innovative preclinical and early-stage clinical assets across AbbVie's core therapeutic growth areas…
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Jardiance (empagliflozin) approved in the EU for the treatment of adults with chronic kidney disease
The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced.…
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Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel…
Astellas Pharma Inc. and PeptiDream Inc. announced a research collaboration and license agreement to discover novel protein degraders for two targets selected by Astellas. Under the…
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Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership
Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., a global leader in generic and innovative medicines and Alvotech, a global biotech company…
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Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for…
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