Latest Biotech News

Kodiak Sciences said its two late-stage eye therapies for wet age-related macular degeneration achieved statistical equivalence to Regeneron’s Eylea in a Phase 3 trial. The company reported that...

Adicet Bio reported early efficacy and safety data for its donor-derived, allogeneic CAR-T approach in lupus nephritis, with half of evaluable patients achieving a complete kidney response at one...

Nutshell Therapeutics (Shanghai) said the FDA cleared its IND for NTS-231, a covalent allosteric molecular glue degrader targeting NRF2. The company said it identified NTS-231 using its Allostar...

Scynexis secured a new BARDA contract worth $214 million to develop a treatment for invasive fungal infections. The award expands federal support for SCY-247, which Scynexis is developing with...

Vasomune Therapeutics completed enrollment in a randomized Phase 2a trial evaluating pegevongitide (AV-001) in patients hospitalized with pneumonia requiring supplemental oxygen. The company is...

Roche said it ended development of an obesity candidate after an interim analysis in a Phase 2 trial suggested the program had limited likelihood of meeting its endpoints. The company halted work...

Merck said it is paying $400 million upfront to license a KRAS G12D inhibitor from China’s SciBrunch Therapeutics, according to the report. The deal values the license at $2.13 billion if future...

Merck and Daiichi Sankyo said they withdrew an FDA accelerated approval application for their B7-H3 ADC, I-DXd, in a specific small cell lung cancer population after FDA feedback indicated the...

Mirum Pharmaceuticals reported that a Phase 3 trial of its chronic hepatitis delta virus therapy candidate hit its primary endpoint. The result advances Mirum’s effort to compete in a space that...

Mirum Pharmaceuticals said the FDA approved Atebrioz, an oral therapy for fibrodysplasia ossificans progressiva, an ultra-rare disorder characterized by progressive bone formation in soft tissue....

The FDA cleared AbbVie’s next-generation Parkinson’s therapy, tavapadon, branded as Juvmo, expanding treatment options for dopamine-agonist–responsive symptoms. The approval marks a regulatory...

Merck and Daiichi Sankyo withdrew their FDA accelerated-approval submission for their B7-H3 antibody-drug conjugate in small cell lung cancer after FDA pushback on available data. The move erases...

Merck agreed to a high-profile licensing deal for a KRAS G12D inhibitor, paying SciBrunch Therapeutics $400 million upfront for global rights to a preclinical candidate, with total deal value...

Kodiak Sciences reported that two vision-focused candidates matched aflibercept in a Phase 3 clinical trial, positioning the company to pursue FDA approval of one eye disease asset during the...

Roche stopped work on emugrobart (GYM329) and returned the muscle-building obesity program to Chugai, ending a trial that tested the experimental medicine with an anti-obesity injectable. The...

Mirum Pharmaceuticals posted a Phase 3 result for its chronic hepatitis delta program, reporting that the trial hit its primary endpoint. The readout advances Mirum’s effort to establish a...

Mirum Pharmaceuticals’ oral therapy, Atebrioz, received FDA approval for fibrodysplasia ossificans progressiva (FOP), making it the third approved drug for the ultra-rare bone growth disorder....

BARDA awarded Scynexis a $214 million contract to develop a treatment for invasive fungal infections. The award supports continued development in a segment where resistant and hard-to-treat...

Medable introduced evidence from a Tufts Center for the Study of Drug Development analysis indicating its Clinical Monitoring Agent can improve clinical research monitor efficiency and potentially...

Researchers reported an AI-guided approach to engineer thermostable, solid-state mRNA vaccines designed to avoid ultra-cold storage constraints. Using an AGENT framework that couples...