FDA advisers endorse Grail's Galleri multicancer blood test, saying benefits outweigh risks
The panel's backing moves Grail's first-of-a-kind blood screening test toward an FDA decision, though advisers said it should not replace guideline-recommended
STAT · +12 outlets
FDA approves Elevar's Lyrfigtu (lirafugratinib) for FGFR2-altered bile duct cancer
The second-line cholangiocarcinoma approval is Elevar's first and marks a first FDA nod for a Korean-developed drug.
GenomeWeb · +10 outlets
FDA commissioner nominee Heidi Overton parries vaccine and abortion questions at Senate hearing
Trump's pick to lead the FDA said she would follow the law and stressed faster early drug research, while declining to detail views on vaccines and abortion.
Biopharmadive · +11 outlets
Enveda raises $311M series E to advance nature-derived AI drug candidates
The AI drug discovery company, which mines plants and microbes for drug prospects, has three candidates in human testing for immune diseases and obesity.
Biopharmadive · +8 outlets
Kyverna's miv-cel cell therapy shows lasting autoimmune benefit at one year
The data move Kyverna closer to launching the first cell therapy for an autoimmune disease even as autoimmune CAR-T peers report safety setbacks.
STAT · +8 outlets
Lilly's once-weekly basal insulin Onswik (efsitora alfa) approved by FDA for type 2 diabetes
The approval gives adults with type 2 diabetes a weekly alternative to daily basal insulin injections.
PR Newswire · +14 outlets
Prime Medicine wins FDA clearance of IND for PM647 AATD gene therapy
The clearance allows clinical testing of a genetic treatment aimed at an alpha-1 antitrypsin deficiency variant carried by roughly 100,000 people in the U.S.
Investing.com · +4 outlets
Lilly signs China partnership with Innocare, its fourth such alliance since January 2025
The deal, worth up to $3.35 billion, underscores Big Pharma's growing reliance on Chinese biotech assets for pipeline growth.
Biopharmadive · +1 outlets
Roche, Ionis RNA drug sefaxersen cuts kidney protein in phase 3 IgA nephropathy study
The win positions Roche to compete with Novartis in the increasingly crowded IgA nephropathy market.
Biopharmadive · +9 outlets
FDA approves first gene therapy for Sanfilippo syndrome type A (Fayuvi)
The Ultragenyx treatment, invented at Nationwide Children's, is the first approved therapy for the rare lysosomal storage disorder.
Medical Xpress · +13 outlets
Zymeworks closes US$929M Theravance acquisition
The Vancouver biotech completes a major deal that reshapes its pipeline and scale.
biv.com · +2 outlets
Merck reports phase 3 success and safety debate for DME eye drug remigromig
The medicine, acquired in a $1.3 billion buyout, cleared the first of two pivotal diabetic macular edema studies but drew analyst scrutiny over safety language.
Biopharmadive · +3 outlets
Compass Therapeutics pushes tovecimig BLA despite FDA demand for new survival trial
The FDA is requiring an additional survival study for the cancer drug, which Compass is contesting while pursuing its filing.
finance.biggo.com · +4 outlets
White House plan to increase control of NIH grants appears 'dead' after bipartisan pushback
A planned executive order that would have expanded White House influence over NIH grants is reportedly no longer moving forward.
STAT · +14 outlets
Novartis bets up to $900M on radioligand therapy from China's BoomRay
The deal adds a Chinese-origin radioligand asset to Novartis's oncology pipeline.
BioSpace · +5 outlets
Senate Finance Committee advances Chris Klomp toward confirmation as HHS deputy secretary
Klomp, a behind-the-scenes HHS official, is likely to be confirmed as second-in-command to RFK Jr.
STAT · +4 outlets
9 pharma leaders sound alarm on biotech's decline in Europe
Top drugmakers are calling for faster clinical trials, stronger IP protections and fiscal flexibility as Europe loses ground to the U.S. and China.
Biopharmadive · +1 outlets
Immunovant ends cutaneous lupus program after phase 2 failure
The setback removes a mid-stage asset from the autoimmune developer's pipeline.
Biopharmadive · +1 outlets