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Bristol Myers spells out Opdivo win in melanoma — how does it stack up against Keytruda?

3 years ago

Scoop: Carisma stole CAR-M Thunder for a while, but a Utah biotech is quietly raising funds to enter the fray

3 years ago

Preapproval and other manufacturing inspections: FDA revises two compliance guides

3 years ago

Pharma TV ad spending dips slightly in third quarter, but still trending ahead of 2021

3 years ago

Clinical trial coordinators sentenced to prison after data falsification scheme

3 years ago

Merck KGaA's French affiliate indicted over investigation into reformulation case

3 years ago

New Torrent Pharmaceuticals Form 483 highlights cleaning and other quality issues

3 years ago

Unsanitary conditions and other QC issues raised by FDA in a warning to contract packager

3 years ago

A pair of storied neuroscience biotechs looks to raise nearly $450M combined (and maybe more) via public offerings

3 years ago

FDA adcomm again votes to pull controversial pre-term birth drug from the market

3 years ago

Two public biotechs seek to merge, focusing on desmoid tumors. But Nasdaq is not guaranteed

3 years ago

Biotech layoffs continue as Ambrx cuts staff and part of its pipeline to extend its cash

3 years ago

Everest climbs closer to Covid-19 booster market; A French upstart snags funds to find drugs

3 years ago

Backed by OrbiMed, Sanofi vet's startup tackles the many mutations of breast cancer at once

3 years ago

Can a little startup equipped with an Eli Lilly castoff make it big with an oncology IPO? In 2022?

3 years ago

FDA commissioner on accelerated approval reforms: 'Need to address as soon as possible'

3 years ago

Novartis-partnered Orionis secures $55M to push cytokine program into clinic

3 years ago

Updated: Zymeworks wanted a Big Pharma partner for its bispecific. Jazz Pharmaceuticals said OK

3 years ago

Updated: In new speed bump for Huntington's, FDA pauses PTC's PhII trial

3 years ago

Drug discovery biotech looking into the ‘dark’ regions of the human genome picks up a $40M+ Series A

3 years ago

Scoop: After hep B setback, an OrbiMed-backed NASH biotech hunts for partners as it raises Series C

3 years ago

Tissue-agnostic drug development: FDA oncology center offers draft guidance

3 years ago

UK regulator selects tiny Massachusetts biotech's potential Gaucher gene therapy for accelerated pathway

3 years ago

J&J holds off on volatile M&A market but has plenty of cash for a deal

3 years ago

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