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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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Cognizant and Gilead Extend Partnership with Five-Year Service Agreement Estimated at $800 Million
Cognizant announced an expansion of its relationship with Gilead Sciences. Gilead is a leading biopharmaceutical company advancing innovative medicines to prevent and treat…
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VANFLYTA First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed…
Daiichi Sankyo announced that VANFLYTA (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) in combination with standard cytarabine and anthracycline induction…
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Ipsen announces European Commission decision on palovarotene for the treatment of FOP
Ipsen announced that the European Commission has followed guidance provided by the Committee for Medicinal Products for Human Use (CHMP) in May this year, and has not granted marketing…
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FDA Approves Veklury (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal 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) in COVID-19…
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Gilead Partners with CHAI and Penta to Improve Treatment and Adherence Rates Among Children with HIV…
Gilead Sciences, Inc. is pleased to announce two public-private partnerships. The first will accelerate the development of an investigational dispersible pediatric formulation…
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FDA approves expanded indication for Novartis Leqvio (inclisiran) to include treatment of adults…
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who…
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Astellas Completes Acquisition of Iveric Bio
Astellas Pharma Inc. announced that it has successfully completed the acquisition of IVERIC bio, Inc. with respect to the announcement on April 30, 2023, through its indirect…
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