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762 News Found

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Anil Koul joins Mankind Pharma as Group Chief Scientific Officer
People | December 15, 2025

Anil Koul joins Mankind Pharma as Group Chief Scientific Officer

More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline


Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO
Clinical Trials | December 12, 2025

Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO

The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA


FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing
Biopharma | December 12, 2025

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification


FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034
News | December 12, 2025

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034


Bristol Myers Squibb unveils breakthrough Lymphoma data
News | December 11, 2025

Bristol Myers Squibb unveils breakthrough Lymphoma data

Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas


Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids
Biopharma | December 10, 2025

Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids

The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities