GSK, Ionis win FDA approval for Hibsago, a first-of-its-kind hepatitis B drug
Hibsago is seen as a potential functional cure for chronic hepatitis B and a key part of GSK's goal of reaching 40 billion pounds in annual revenue by 2031.
Biopharmadive · +10 outlets
Moderna nears release of Phase 3 melanoma vaccine data as shares swing
Moderna and Merck are preparing an FDA filing for their personalized mRNA melanoma vaccine paired with Keytruda, making the upcoming Phase 3 readout a major tes
24/7 Wall St. · +13 outlets
Roche strikes up to $15B deal with China's Hansoh for antibody-drug conjugates
The pact underscores Western pharma's growing reliance on Chinese biotech for new drug candidates.
STAT · +4 outlets
Roivant's brepocitinib succeeds in non-infectious uveitis trial
The positive eye disease results follow a recent dermatomyositis clearance and could open a new market for the immune drug.
Biopharmadive · +9 outlets
Arcus kidney cancer data impresses analysts as drug rivals Merck's
Follow-up results suggest Arcus' casdatifan might be superior to a marketed Merck medicine, sending shares higher.
Biopharmadive · +2 outlets
Clene submits NDA seeking accelerated approval for oral ALS drug
The filing moves an experimental oral ALS treatment closer to a potential FDA decision.
NeurologyLive · +4 outlets
CMS extends Medicaid fraud crackdown to New York adult day care program
The move is part of a broader federal focus on alleged health care fraud in home and community-based care.
STAT · +10 outlets
Nigeria confirms travel-related Ebola case tied to DRC outbreak
Nigeria becomes the fifth country to identify an infection linked to the ongoing outbreak centered in the Democratic Republic of the Congo.
STAT · +14 outlets
Mark Cuban's Cost Plus Drugs targets rare disease and n-of-1 gene therapy market
Cuban says the company can cut manufacturing costs for custom rare disease drugs and bespoke gene therapies.
STAT · +4 outlets
ICER finds most new drugs launched at prices above cost-effectiveness thresholds
Net launch prices for new medicines rose about 35% from 2022 to 2025, according to the non-profit analysis.
Biopharmadive · +14 outlets
FDA approves new weight-loss drug
The approval adds another option to the fast-growing obesity treatment market; multiple outlets are aggregating the same regulatory news.
BusinessWorld Online · +14 outlets
Immatics awaits pivotal Phase 3 melanoma results for its cell therapy
After a quarter century of work, the German biotech faces a make-or-break moment for its PRAME-targeting lead candidate.
STAT · +1 outlets
Rapport's epilepsy drug finds surprising success in bipolar mania trial
RAP-219 narrowly hit the main goal of a mid-stage study, potentially opening a billion-dollar market.
Biopharmadive · +3 outlets
Hologic acquires Catalan biotech Reveal Genomics
The US diagnostics company is buying the Spanish genomic testing developer.
Diari ARA · +1 outlets
LG Chem to use AI for patient selection, targets 2029 personalized cancer vaccine trial
The Korean chemical and life sciences group is expanding AI into clinical development as it pushes a personalized cancer vaccine program.
BigGo Finance · +5 outlets
Cosette lands FDA approval for Evoxac liquid in Sjogren's disease
The liquid formulation offers an alternative to capsules for dry mouth in adults with Sjogren's.
Fierce Pharma · +2 outlets
BioNTech opens mRNA manufacturing facility
The new plant expands mRNA production capacity amid shifting demand for the technology.
Mirage News
Pharma's hottest R&D bets still lack clinical proof, analysis finds
New bispecifics, antibody-drug conjugates and cell therapies have not yet proven themselves in the clinic despite billions in spending.
Biopharmadive