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Approval · news · pharmadog
← back to Approval
News · Approval
1,123
stories
12d
Kyverna says long-term data bolster FDA submission for rare autoimmune CAR-T
endpoints
12d
STAT+: Momentum is building for a big change to how doctors get paid
stat
12d
Roche pens backloaded $2B deal with Atavistik to discover allosteric CVRM drugs
fiercebiotech
12d
Adagio Medical kicks off strategic review, trims more than half its staff
fiercebiotech
12d
Growth mode: 3 biotechs that are staffing up after series B raises
biospace
12d
Grail survives adcomm vote as it awaits FDA decision for cancer blood test
fiercebiotech
12d
Euro Roundup: EMA officials argue against making single pivotal trials the ‘rigid, default position’
raps
12d
FDA adcomm votes in favor of benefit-risk of Grail’s cancer test
endpoints
12d
Roche, Ionis RNA drug scores in kidney disease study
biopharma dive
12d
New approach methodologies in safety and toxicology testing: Why proving repeatability is the next hurdle for widespread adoption
fiercebiotech
12d
Amgen asset from $27.8B Horizon buy scores in Phase 3 Sjögren's study
biospace
12d
Roche-Ionis’ RNA therapy reduces kidney disease marker, opening path to swift FDA nod
biospace
12d
STAT+: Flagship gets a Pentagon contract
stat
13d
STAT+: Pharmalittle: We’re reading about a closing loophole for importing meds, European competitiveness, and more
stat
13d
Novartis bets up to $900M for radioligand therapy from China’s BoomRay
biospace
13d
Ionis-Otsuka offer 'groundbreaking' improvement in function and survival for genetic type of ALS
biospace
13d
Roche kidney drug's Phase 3 win sets up path to accelerated approval
endpoints
13d
Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz
biospace
13d
STAT+: A private equity-owned hospital chain is becoming a nonprofit. Is it just a bailout for investors?
stat
13d
STAT+: Drugmakers, biotech VCs show ‘reinvigorated’ interest in osteoporosis treatments
stat
13d
ReCode CEO Suliman leaves cystic fibrosis mission in mentee’s hands
biospace
13d
China’s surging biotech sector represents both competition and lifeline for the US
biospace
13d
Roche’s phase 3 win tees up fight with Novartis for blockbuster kidney disease market
fiercebiotech
13d
Amgen reports a Phase 3 win with Sjögren’s drug candidate
biopharma dive
13d
Opinion: Former FDA commissioners: Heidi Overton has an opportunity to strengthen the FDA
stat
13d
Compass vows to press on with FDA application despite new trial request
biospace
13d
Celldex sinks as safety concerns cloud immune drug results
biopharma dive
13d
Vertex opens up larger kidney disease opportunity with mid-stage readout
biospace
13d
STAT+: Novo may be getting a better deal than expected with Medicare’s Bridge program
stat
13d
2026 IPO blitz continues with 4 new biotech filings
biospace
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