Novo Nordisk to pay up to $1.3B for Nanexa's long-acting injectable drug delivery technology
The Swedish biotech's shares roughly doubled as Novo licenses a platform aimed at extending dosing intervals for obesity and diabetes drugs, part of Novo's push
WSJ · +15 outlets
FDA approves Merck's belzutifan-lenvatinib combo for advanced kidney cancer
The Welireg plus Lenvima pairing becomes the first approved combination for previously treated advanced clear cell renal cell carcinoma.
AJMC · +14 outlets
Eli Lilly's Olumiant wins FDA expansion for severe alopecia areata in children as young as 12
The label expansion makes Lilly's JAK inhibitor the first systemic medicine cleared for adolescents with severe immune-related hair loss.
GuruFocus · +6 outlets
FDA advisers narrowly vote to add six peptides to the drug compounding list
The advisory panel vote could open a path for compounded versions of peptides currently restricted to brand-name products.
AJMC · +13 outlets
Merck and Daiichi Sankyo withdraw FDA application for lung cancer drug ifinatamab deruxtecan
The companies pulled the submission while a phase 3 trial in the same setting continues enrolling patients.
Mugglehead Investment Magazine · +14 outlets
Nanexa surge aside, CGT and biotech stocks hit 52-week highs as sector rallies
Barron's and others point to innovation-driven momentum, with Moderna pacing S&P 500 gainers and several smaller healthcare names outpacing it.
RTTNews · +2 outlets
Gene-silencing biotech ADARx makes market debut with $535M raise
The offering adds another sizeable listing to a biotech IPO window that has been widening through the year.
MedCity News · +1 outlets
Durvalumab plus enfortumab vedotin gets FDA priority review in muscle-invasive bladder cancer
The accelerated review signals a potential new perioperative option for MIBC patients.
CancerNetwork · +8 outlets
Lilly brings more heat to Novo with FDA approval for once-weekly insulin Onswik
The weekly basal insulin adds a convenience claim in a diabetes market where Lilly and Novo compete head to head.
fiercepharma.com · +11 outlets
Prime Medicine receives FDA clearance for gene editing study
Regulators cleared the company to begin human testing of a prime-editing candidate, a first for the platform's clinical push.
Benzinga · +14 outlets
Experimental ALS treatment linked to 65% lower risk of death
The reported mortality signal is notable in a disease where treatment options remain scarce.
stocktitan.net · +1 outlets
Etentamig clears the bar against standard therapy in triple-class exposed myeloma
The results support the bispecific's positioning in heavily pretreated multiple myeloma patients.
Pharmacy Times · +2 outlets
FDA panel backs Galleri $949 multi-cancer blood test, approval questions remain
The advisory vote moves a widely watched early-detection test closer to a regulatory decision despite cost and evidence doubts.
The Economic Times · +6 outlets
Pharming's Joenja gets FDA priority review for lower dose in younger children
The review covers dosing for children weighing 13 to 27 kilograms, below the current approved weight threshold.
stocktitan.net · +4 outlets
Lilly faces criticism for 'promotional and emotive' language in GLP-1 press release
The pushback highlights tightening scrutiny of how obesity drugmakers frame clinical data for investors and patients.
fiercepharma.com · +1 outlets
Merck withdraws lung cancer application as a phase 3 trial keeps enrolling
The move removes a near-term regulatory catalyst for Merck's oncology pipeline in that indication.
stocktitan.net
Nektar wins $90 million jury award from Eli Lilly, stock barely moves
The verdict resolves one legal dispute but leaves questions about the larger litigation picture and Lilly's exposure.
TIKR.com · +1 outlets
Newron updates on ENIGMA-TRS 2 study as FDA hold persists on U.S. arm of evenamide trial
The clinical hold on the U.S. portion of the schizophrenia study keeps a key program in regulatory limbo.
TipRanks · +1 outlets