Latest Biotech News

ROSETTA Lung-02 showed encouraging first-line activity for pumitamig (BNT327/BMS986545) combined with chemotherapy in non–small cell lung cancer, presented at the 2026 ASCO Annual Meeting. In the...

Merck’s Welireg (belzutifan) plus Keytruda (pembrolizumab) gained FDA approval for adjuvant use in clear cell renal cell carcinoma, marking the first approval for a PD-1 and HIF-2 alpha inhibitor...

The FDA approved Colorado’s proposal to import cheaper drugs from Canada, according to a letter referenced in reporting. While the step clears an initial regulatory hurdle, the timeline and...

Vedana Therapeutics emerged from stealth with a $46 million Series A to develop its internally discovered antibody programs for migraine prevention. The startup’s pipeline focuses on...

Neumora Therapeutics ended its major depression program after two Phase 3 failures for navacaprant (a kappa opioid receptor antagonist), triggering a 35% workforce reduction. The biotech said the...

Invitae is facing a class action alleging that its genetic data was illegally shared with Labcorp following Labcorp’s acquisition of Invitae assets in 2024. The complaint, filed in Illinois,...

A new analysis warns that proposed White House regulations could terminate nearly 5,000 clinical trials, including about 1,000 cancer studies. The report from science advocacy group Stand Up for...

Edgewise Therapeutics is preparing for Phase 3 in hypertrophic cardiomyopathy after reporting updated Phase 2 evidence for EDG-7500. The company said the updated part D results from Cirrus-HCM...

Germany backed away from a plan to implement variable discount pricing on branded drugs, Reuters reporting that opposition from drugmakers drove the change. The proposed discount initiative was...

Merck and Protillion Biosciences launched a multi-target AI drug discovery collaboration with potential milestone payments of up to $510 million, pairing Protillion’s Prot-MaP on-chip antibody...

Pumitamig (BNT327/BMS986545) plus chemotherapy delivered high response rates in ROSETTA Lung-02, a phase 2 study of first-line non–small cell lung cancer presented at the 2026 ASCO Annual Meeting....

Merck’s Welireg (belzutifan) combined with Keytruda (pembrolizumab) received FDA approval for intermediate-high or high-risk, recurrence-free adjuvant treatment in clear cell renal cell carcinoma...

Clinical evidence and regulatory review frameworks moved again around Moderna’s seasonal mRNA flu vaccine mRNA-1010 (mFLUSIVA). FDA documents ahead of the Vaccines and Related Biological Products...

China’s National Medical Products Administration approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) via priority review for adults with locally advanced or metastatic...

Vedana Therapeutics emerged from stealth with a $46 million Series A to develop internally discovered anti-PACAP antibody programs for migraine prevention, positioning its platform around...

Eli Lilly continued its non-opioid pain acquisition sprint by buying 4E Therapeutics, adding early-stage MNK inhibitor programs designed to target chronic pain without addiction risk. 4E’s lead...

Oricell Therapeutics advanced its glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, into confirmatory registration phase II for patients with GPC3-positive advanced hepatocellular...

Neumora Therapeutics discontinued navacaprant after two phase 3 flops in major depressive disorder, failing to meet primary and key secondary endpoints in KOASTAL-2 and KOASTAL-3. The company also...

Tune Therapeutics’ TUNE-401 epigenome editing therapy advanced with strong early clinical signals in a phase 1 study, reporting antiviral activity and safety data for its approach to add...

Merck & Co. launched a multi-target discovery collaboration and license agreement with Protillion Biosciences, setting up new AI-discovered therapeutic candidates built on Protillion’s Prot-MaP...