FDA approves Elevar's Lyrfigtu for FGFR2-altered bile duct cancer, a first for a Korean firm
Elevar (with Korean partner HLB) won its first FDA approval for a second-line FGFR2-rearranged cholangiocarcinoma drug, with a US launch planned for Q4.
GenomeWeb · +10 outlets
FDA approves Eli Lilly's Onswik, a once-weekly basal insulin for type 2 diabetes
Onswik (insulin efsitora alfa-gobe) gives adults with type 2 diabetes a weekly alternative to daily long-acting insulin injections.
STAT · +14 outlets
FDA advisers back Grail's multi-cancer blood test, saying benefits outweigh risks
An FDA advisory panel endorsed the first-of-a-kind blood test while cautioning it should not replace guideline-recommended cancer screenings.
Biopharmadive · +9 outlets
Prime Medicine gets FDA clearance to start AATD gene editing trial
The clearance covers an in vivo gene editing treatment for alpha-1 antitrypsin deficiency, a variant carried by roughly 100,000 people in the US.
Investing.com · +9 outlets
Merck, Daiichi Sankyo withdraw FDA application for ifinatamab deruxtecan
The companies pulled their filing for the ADC cancer drug, a setback for a closely watched pipeline asset.
Mugglehead Investment Magazine · +9 outlets
Mirum wins FDA approval for ultra-rare bone lesion disorder drug, deepening Regeneron rivalry
The approval expands the competitive field in a niche bone disease category where Regeneron also competes.
Fierce Pharma · +1 outlets
Kyverna cell therapy shows lasting autoimmune benefit in one-year data
New miv-cel data move Kyverna closer to the first cell therapy for an autoimmune disease, even as rival autoimmune CAR-T programs hit safety issues.
STAT · +14 outlets
Ulefnersen slows ALS progression in Phase 3 trial, BioPharma Dive notes RNA drug success
The RNA-targeted therapy slowed disease progression in a Phase 3 ALS study, a notable win for the modality.
Drug Discovery News · +1 outlets
J&J, Legend report long-term Carvykti survival data in multiple myeloma
Five-year CARTITUDE-2 data show durable treatment-free remission for Carvykti in earlier-line multiple myeloma.
BioSpace · +14 outlets
Merck reports pivotal win for $3B eye disease prospect remigromig in diabetic macular edema
The acquired drug succeeded in the first of two pivotal DME studies, though safety language drew analyst debate.
Biopharmadive · +1 outlets
Moderna hits multi-year high as Bernstein calls intismeran clearest mRNA platform validation
Moderna shares reached fresh 52-week and multi-year peaks amid investor enthusiasm for its mRNA cancer vaccine and reported UAE investment talks.
The Crypto Basic · +4 outlets
FDA nominee Heidi Overton parries vaccine, abortion and China questions at Senate hearing
Trump's pick to lead the FDA said she would follow the law on key decisions while pledging to speed early drug research.
Biopharmadive · +12 outlets
Novo Nordisk pursues long-acting obesity drugs in new alliance; Acadia slumps on Alzheimer's data
Novo's latest partnership covers injectables dosed every one to three months, while Acadia's Alzheimer's data disappointed investors.
Biopharmadive · +2 outlets
ADARx raises $446M in IPO, first US RNAi biotech listing in over a decade
The RNAi drug developer is the only RNA-based drugmaker to go public since 2024.
Biopharmadive · +3 outlets
mRNA immunotherapy eliminates pancreatic cancer in mice, Penn trial data draw attention
A promising personalized mRNA cancer vaccine tested with Penn support is being watched as a template for the field.
SciTechDaily · +3 outlets
aTyr Pharma reaches FDA protocol agreement for efzofitimod Phase 3 sarcoidosis trial
The agreement clears a path for a late-stage study of efzofitimod in pulmonary sarcoidosis.
The Clinical Trial Vanguard · +7 outlets
Basecamp Research raises $140M to advance AI-designed medicines
The funding adds to a run of large rounds for AI drug discovery startups.
Indian Pharma Post · +1 outlets
Enveda raises $311M to push nature-derived drug candidates into trials
The round funds clinical advancement of medicines derived from natural products.
news.lavx.hu · +1 outlets