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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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SK bioscience- Government Pharmaceutical Organization Sign Memorandum of Understanding to Strengthen…
SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the company has signed a Memorandum of Understanding…
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Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for…
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Lilly to Acquire Sigilon Therapeutics
Eli Lilly and Company and Sigilon Therapeutics, Inc. announced a definitive agreement for Lilly to acquire Sigilon, a biopharmaceutical company that seeks to develop functional cures…
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GSK completes acquisition of BELLUS Health
GSK plc and BELLUS Health Inc. announced GSK has completed the acquisition of BELLUS, a biopharmaceutical company working to better the lives of patients suffering from refractory…
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Xigduo XR approved in China for adults with type-2 diabetes
AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products…
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GSK receives US FDA Fast Track designation for investigational vaccine against gonorrhoea
GSK plc announced the US Food and Drug Administration (FDA) has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is…
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FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of…
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FDA approves Jardiance (empagliflozin) for the treatment of type 2 diabetes in children 10 years and…
The U.S. Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and…
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Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology
Eli Lilly and Company and DICE Therapeutics, Inc. announced a definitive agreement for Lilly to acquire DICE.
DICE is a biopharmaceutical company that leverages its proprietary…
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