Latest Biotech News

Gilead won US approval for its hepatitis D drug Hepcludex (bulevirtide), four years after the FDA previously rejected the therapy over manufacturing and distribution concerns. The approval...

Eli Lilly reported top-line Phase 3 results for retatrutide (Triumph-1), showing up to 28% average body-weight loss over 80 weeks in people with obesity, with different dosing arms meeting primary...

Updated findings from the RUBY phase 3 trial suggested a durable progression-free survival benefit from dostarlimab plus chemotherapy in mismatch repair–deficient (dMMR)/microsatellite...

Parabilis filed for an initial public offering (IPO) one day after signing a strategic research collaboration with Regeneron valued at up to $2.3 billion. The collaboration targets...

Seegene received CE IVDR marking for its Allplex MDRO Assay, a multiplex real-time PCR test designed to detect multidrug-resistant organisms tied to healthcare-associated infections. The assay is...

Bristol Myers Squibb expanded enterprise AI deployment by partnering with Anthropic to roll out Claude across global operations, aiming to accelerate multiple stages of drug discovery and...

InSphero acquired cell-based assay services provider PhenoVista Biosciences to expand access to high-content imaging and phenotypic assay technologies and services. InSphero said the deal...

WHO and CDC increased diagnostic testing focus for the Bundibugyo Ebola strain as the outbreak expands in parts of the Democratic Republic of Congo and Uganda. WHO raised the threat level from...

The FDA approved AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan-dlnk) as a first-line option for adults with unresectable or metastatic...

Gilead secured US approval for bulevirtide (Hepcludex), restarting a program the FDA rejected about four years earlier over manufacturing and distribution concerns. The approval reopens a...

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’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...

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...

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 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 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...

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 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...

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...

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,...