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FDA raises bar for CAR‑T: new guidance demands superiority evidence
Vinay Prasad, director in FDA biologics, and agency commentary signaled a higher evidentiary bar for new CAR‑T approvals, arguing that novel cell therapies must demonstrate superiority over...
ASH: MRD surrogate in AML — pooled data advocates faster approvals
Researchers presented pooled Harmony Alliance data at ASH supporting measurable residual disease (MRD) as a surrogate endpoint in acute myeloid leukemia (AML), arguing it could identify effective...
Terns rises as Novartis rival: leukemia drug posts strong molecular responses
Terns Pharmaceuticals reported early clinical data showing its oral targeted agent TERN‑701 produced high major molecular response rates in heavily pretreated chronic myeloid leukemia (CML)...
Mirum snaps up Bluejay: $620M buy brings phase‑3 hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for roughly $620 million in cash and stock to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D...
Dyne readies FDA push: Duchenne exon‑51 drug posts landmark dystrophin gains
Dyne Therapeutics reported pivotal study success for its exon‑51 skipping therapy in Duchenne muscular dystrophy (DMD) and said it will move toward an accelerated approval filing with the FDA. The...
Kymera’s signals: pill reduces eczema while degrader shows biologic‑like biomarker activity
Kymera Therapeutics reported two early but impactful readouts: an oral candidate, KT‑621, produced a rapid clinical improvement in atopic dermatitis patients, and a separate STAT6 degrader program...
Structure surges: oral GLP‑1 pill posts up to 15% weight loss — tolerability debate looms
Structure Therapeutics reported mid‑stage data for its oral GLP‑1 candidate aleniglipron showing up to 15% placebo‑adjusted weight loss in Phase IIb cohorts, reviving investor interest in oral...
Wave’s RNA approach trims visceral fat and preserves muscle — early signals lift stock
Wave Life Sciences disclosed interim Phase 1 data showing its siRNA obesity candidate reduced visceral fat while maintaining or improving muscle mass markers, an outcome the company said compares...
BioNTech’s CTLA‑4 antibody improves survival — efficacy offsets tolerability concerns
BioNTech and OncoC4 reported Phase 3 survival data for their anti‑CTLA‑4 candidate that showed a large reduction in death risk in lung cancer, but subsequent analysis highlighted a challenging...
FDA sets higher bar for CAR‑T: superiority now expected — pivotal readouts test the claim
The FDA’s biologics chief argued in a journal article that new CAR‑T therapies will need to demonstrate superiority over existing standards to secure approval, signaling a tougher regulatory path...
KRAS G12D: more than 20 programs launch — companies race to drug common mutation
BioCentury reported an accelerating wave of programs targeting the KRAS G12D mutation, with more than 20 initiatives launched in the past year across biotech and Big Pharma. Companies are...
Medtronic’s Hugo RAS cleared by FDA — a new rival to da Vinci in soft‑tissue surgery
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system, a regulatory milestone that gives the device maker a direct platform to challenge Intuitive Surgical’s da Vinci...
ASH nudge for AML: MRD surrogate endorsed — targeted therapies outpace chemo
Researchers presented pooled data at ASH supporting measurable residual disease (MRD) as a surrogate endpoint that could accelerate acute myeloid leukemia (AML) drug development, enabling earlier...
Dyne’s Duchenne win — FDA filing in sights
Dyne Therapeutics reported that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and is preparing a regulatory submission. The company presented registrational...
Mirum buys Bluejay’s hepatitis D asset — $620M deal
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D virus (HDV). The transaction calls for $620...
Terns’ CML candidate pressures Novartis — ASH update
Terns Pharmaceuticals presented early ASH data showing its targeted chronic myeloid leukemia (CML) drug produced high molecular response rates in heavily pretreated patients. An interim readout...
Oral GLP‑1 race heats up — efficacy vs tolerability
Two oral GLP‑1 candidates reported mid‑stage efficacy that keeps the small‑molecule obesity race competitive with injectables. Structure Therapeutics reported placebo‑adjusted weight loss near...
FDA raises the bar for CAR‑T approvals
The FDA signaled a policy shift that will require new CAR‑T therapies to demonstrate superiority over existing treatments to secure approval, according to a journal article by the agency’s...
Gilead’s anito‑cel posts deep myeloma responses at ASH
Gilead and partner Arcellx reported pivotal‑stage results for anito‑cel in multiple myeloma showing high response rates and deep remissions. In a cohort of 117 patients, companies disclosed a 96%...
MRD surrogate could speed AML approvals — Harmony data
Researchers presented pooled Harmony Alliance data at ASH indicating that measurable residual disease (MRD) may serve as a surrogate endpoint to accelerate acute myeloid leukemia (AML) trials. The...