Latest Biotech News

The FDA’s Center for Biologics Evaluation and Research granted NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle platform, which measures vector genome and...

Grail submitted a premarket approval application to the FDA for its Galleri multi‑cancer early‑detection blood test, drawing on performance and safety data from more than 25,000 patients in...

Quince Therapeutics reported top‑line Neat Phase III results for its erythrocyte‑encapsulated dexamethasone (eDSP) in ataxia‑telangiectasia that failed to meet the primary endpoint; the company...

Moderna announced the departure of Chief Medical Officer Jacqueline Miller after roughly a year in the role and concurrently out‑licensed a Phase‑3 rare‑disease asset to Recordati for $50 million...

The FDA released a complete response letter and asserted it had raised serious concerns with Corcept Therapeutics prior to the company’s submission for a Cushing’s syndrome therapy, contradicting...

Investigators reported that a DNA‑based immunotherapy produced substantial survival gains in clinical trials for ovarian cancer, offering the most meaningful efficacy signal in decades for the...

AstraZeneca struck multiple, high-value agreements with China’s CSPC to bulk up its obesity and metabolic portfolio while accelerating in-country R&D and manufacturing. The companies committed an...

Eli Lilly disclosed a $3.5 billion investment to build a Lehigh Valley manufacturing complex that will produce retatrutide and other next‑generation obesity injectables. The new facility is...

The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle/Tessie platform, validating a multiplex assay for direct measurement of AAV vector genome integrity...

Illumina completed its acquisition of SomaLogic and related assets for $350 million plus contingent payments, adding the SomaScan proteomic platform and a CLIA/CAP lab in Boulder to its portfolio....

Quince Therapeutics said its pivotal Phase III Neat trial of dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) failed to meet its primary endpoint in...

European regulators have opened a review of Amgen’s Tavneos (avacopan) after new information raised questions about the integrity of the Advocate trial data that supported the drug’s initial...

Grail submitted its Galleri multi‑cancer early detection test to the FDA for premarket approval, citing performance and safety data from more than 25,000 patients drawn from the Pathfinder 2 study...

Beckman Coulter Life Sciences announced a strategic partnership to integrate its liquid‑handling and cell‑analysis instruments with Automata’s LINQ AI‑ready automation platform, aiming to deliver...

Ultragenyx Pharmaceuticals resubmitted an application to the FDA seeking approval for UX111, an AAV‑based gene therapy for Sanfilippo syndrome type A, following an earlier rejection last summer....

Repertoire Immune Medicines signed a collaboration with Eli Lilly to develop tolerizing therapies for several autoimmune indications. The agreement provides an $85 million upfront payment and...

AstraZeneca moved decisively to bulk up its obesity and metabolic pipeline by striking a wide-ranging partnership with China’s CSPC Pharmaceutical Group and committing major investments in the...

Beckman Coulter Life Sciences announced a strategic partnership with London automation firm Automata to integrate liquid‑handling and cell analysis instruments into Automata’s LINQ AI‑ready...

The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle/Tessie platform, recognizing the technology as a regulatory‑relevant approach for multiplexed quality...

Illumina closed its acquisition of SomaLogic and related assets from Standard BioTools, paying $350 million in cash plus up to $75 million in near‑term milestones and royalties. The deal brings...