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3991 News Found

Bayer wins Japan nod for finerenone in broad heart failure population
Drug Approval | December 23, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients


FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
Drug Approval | December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care


LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer
Clinical Trials | December 23, 2025

LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer

The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy


Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial
News | December 23, 2025

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial

According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million


Biocon inks out-licensing agreement with Ajanta to market Semaglutide in 26 countries
News | December 23, 2025

Biocon inks out-licensing agreement with Ajanta to market Semaglutide in 26 countries

Biocon will be responsible for supplying Semaglutide to Ajanta for exclusive marketing in 23 countries and semi-exclusive marketing in 3 countries across Africa, Middle East and Central Asia


Zydus Partners with Bioeq for US commercialisation rights for Nufymco
News | December 23, 2025

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA


Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial
Clinical Trials | December 22, 2025

Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial

The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile


Ipsen’s FALKON trial falls short in rare FOP study, offers key insights
Clinical Trials | December 22, 2025

Ipsen’s FALKON trial falls short in rare FOP study, offers key insights

FOP is a rare genetic disorder caused by mutations in the ALK2 kinase


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia


Samsung Biologics strengthens U.S. presence with acquisition of GSK’s Human Genome Sciences or $280 million
Biopharma | December 22, 2025

Samsung Biologics strengthens U.S. presence with acquisition of GSK’s Human Genome Sciences or $280 million

Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs