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Merck’s Kelun-linked ADC posts first randomized phase 3 win in China NSCLC
Merck and Kelun-Biotech reported a Phase 3 result for sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (Keytruda) that cut the risk of disease progression or death by 65% versus Keytruda alone...
AstraZeneca gets EU positive opinion despite adverse FDA panel vote
AstraZeneca’s breast cancer drug received a positive opinion from EU regulators, following an FDA advisory committee vote against the drug in April. The EU outcome provides a regulatory path...
Datopotamab competitor Datroway—new US breast cancer label expands TROP2 ADC positioning
Separately from the EMA line, the Datroway approval reinforces TROP2-directed ADC competition in TNBC where treatment options remain constrained. The approval expands the label to an earlier-line...
Clinical durability in endometrial cancer with dostarlimab plus chemo
Updated findings from the phase 3 RUBY trial suggest durable disease control for dostarlimab (Jemperli) combined with carboplatin and paclitaxel in dMMR/MSI-H primary advanced or recurrent...
Oorja raises $30M to push IPF drug program into mid-stage
Oorja Bio Inc. secured $30 million in a Series A round from founding investor Westlake Biopartners to advance its in-licensing approach for idiopathic pulmonary fibrosis (IPF) and related fibrotic...
Parabilis files for IPO ahead of large Regeneron collaboration
Parabilis Medicines filed for an initial public offering a day after signing an up-to-$2.3 billion strategic research collaboration with Regeneron. Under the deal, the companies will discover and...
Global oncology pipeline readout at ASCO26: sac-TMT strategy expands competition
Ahead of ASCO 2026, Merck’s licensed TROP2 ADC sacituzumab tirumotecan (sac-TMT) drew investor attention after OptiTROP-Lung05 interim Phase 3 data showed a major PFS cut versus Keytruda alone in...
Vizgen restructures after earlier funding
Vizgen laid off an undisclosed number of employees as part of a strategic reorganization, the company said without detailing impacted roles. In communications, Vizgen tied the change to investing...
FDA approval for a new TROP2 ADC in triple-negative breast cancer
The FDA approved Datroway (TROP2-directed antibody-drug conjugate) as a first-line treatment option for triple-negative breast cancer, advancing Daiichi Sankyo and AstraZeneca’s ADC strategy in an...
ASCO 2026 Phase 3 data sets up a frontline NSCLC benchmark fight for sac-TMT
Merck and Kelun-Biotech’s TROP2-directed ADC sacituzumab tirumotecan (sac-TMT) delivered a major Phase 3 progression-free survival result in first-line, PD-L1-positive non-small cell lung cancer,...
Biogen and Denali abandon LRRK2 approach after Phase 2b failure in Parkinson’s
Biogen and Denali Therapeutics dropped BIIB122 in idiopathic Parkinson’s after a Phase 2b trial missed its primary endpoint, according to updated results reported to industry. The randomized study...
Retatrutide’s Phase 3 obesity results strengthen Lilly’s triple-agonist position
Eli Lilly reported Phase 3 results for retatrutide (a triple-agonist targeting GIP/GLP-1/glucagon receptors), showing dose-dependent weight loss up to 28% over 80 weeks in its Triumph-1 trial,...
Gene therapy and regulatory pipeline: FDA clearance for Qihan Biotech’s universal allogeneic CAR T
Hangzhou Qihan Biotech received FDA IND clearance for QT-019C, a universal allogeneic CAR T-cell therapy designed for autoimmune diseases. The therapy is engineered to stably express two CARs...
Platform deal: Bristol Myers Squibb partners with Anthropic to deploy Claude enterprise-wide
Bristol Myers Squibb announced a partnership with Anthropic to deploy Claude AI across the company’s global operations, aiming to accelerate drug discovery and development through enterprise-wide...
Diagnostics regulation: FDA approves FoundationOne CDx as companion diagnostic for Tepmetko
The FDA approved Foundation Medicine’s FoundationOne CDx tissue assay as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib) to identify metastatic non-small cell lung cancer patients...
Corporate action: InSphero buys PhenoVista Biosciences to expand phenotypic assay portfolio
InSphero acquired PhenoVista Biosciences, a cell-based assay services provider, to expand its high-content imaging and phenotypic assay capabilities for drug development. The deal adds services...
US regulatory crackdown on GLP-1 imports: FDA warning letter over semaglutide API safeguards
The FDA issued a warning letter to a Chinese supplier, Harbin Jixianglong Biotech, after inspectors found alleged compliance failures involving semaglutide API shipments amid the agency’s “green...
Backed by Westlake: Oorja plans mid-stage IPF study with new financing context
Oorja Bio, backed by Westlake, is planning a mid-stage study for an idiopathic pulmonary fibrosis (IPF) candidate, according to a venture-focused update. The report frames the move as a step to...
Obesity drug efficacy milestone for retatrutide
Eli Lilly reported Phase 3 “Triumph-1” top-line results for retatrutide, a triple-hormone (GIP/GLP-1/glucagon) obesity injection, showing dose-dependent weight loss and a generally expected...
PD-(L)1xTROP2 ADC combo moves toward frontline lung cancer standard
Merck and Kelun-Biotech’s sacituzumab tirumotecan (sac-TMT) scored a first randomized Phase 3 win in treatment-naïve, PD-L1-positive non-small cell lung cancer, cutting the risk of disease...