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FDA spells out how cancer drug developers can use one trial for both accelerated and full approvals
3 years ago
R&D
Relmada makes 'critical changes' to PhIII trial to try and save depression drug
3 years ago
R&D
NK cell therapy-focused biotech eyes SPAC deal
3 years ago
Deals
Incyte hit by CRL on extended-release JAK tablets, muddying plans for Jakafi franchise expansion
3 years ago
Pharma
FDA+
Hard pressed for cash, Cyclerion looks for help funding rare disease drug
3 years ago
R&D
Brii Biosciences stops manufacturing Covid-19 antibody combo, plans to withdraw EUA request
3 years ago
R&D
China
Three's a crowd as another Kite exec hits the exit; Surfing tough waters, Celyad Oncology picks up new CEO
3 years ago
Peer Review
Patients appeal NIH's rejection to use 'march-in' rights on Astellas' prostate cancer drug Xtandi
3 years ago
Law
Takeda and Lundbeck change tactics on Trintellix depression campaign
3 years ago
Pharma
Marketing
European Commission delays proposal for major changes to pharma legislation
3 years ago
Pharma
FDA+
Bristol Myers’ ‘Living’ documentary ties together people managing health conditions
3 years ago
Pharma
Marketing
Secura Bio to keep offering blood cancer drug despite negative ODAC vote, OS questions
3 years ago
Pharma
J&J loses attempt to extend patent in India for tuberculosis drug
3 years ago
Pharma
White House unveils ‘bold goals’ for US biomanufacturing efforts
3 years ago
Pharma
Manufacturing
Contract manufacturer Curia names new CEO
3 years ago
People
Manufacturing
Takeda invests $760M+ into new plasma-derived therapy manufacturing site in Japan
3 years ago
Pharma
Manufacturing
Manufacturing roundup: Canada to invest $58M+ into 'critical' medicines manufacturing; FDA to accept apps for CMC ...
3 years ago
Manufacturing
Moderna partners on non-viral gene therapy with Generation Bio after swinging gene editing deals
3 years ago
Deals
R&D
Royalty Pharma hands off $100M upfront for PureTech royalty on Karuna's schizophrenia hopeful
3 years ago
Deals
R&D
Gilead passes on fully acquiring Pionyr, as eyes now turn to Tizona, a fellow summer 2020 buyout option
3 years ago
Startups
Deals
FDA approves Cidara's Rezzayo as antifungal treatment for candidemia and invasive candidiasis
3 years ago
R&D
FDA+
Updated: Ex-Seagen chief Clay Siegall emerges as CEO of private biotech
3 years ago
People
Sanofi, Regeneron boast PhIII win with Dupixent in COPD, clearing first bar for expansion
3 years ago
R&D
Pharma
Genentech to halt commercial manufacturing in California HQ, with layoffs attached
3 years ago
People
Manufacturing
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