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FDA clears GSK’s twice-yearly asthma drug – dosing edge
GSK won U.S. Food and Drug Administration approval for depemokimab (brand name Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The...
Viaskin peanut patch: Phase III success sends DBV back to FDA
DBV Technologies reported positive top‑line results from its pivotal Phase III Vitesse trial of the Viaskin peanut patch in children aged 4–7. The study met its primary endpoint: roughly 46.6% of...
Atavistik raises $120M – backing blood‑disease small molecules
Atavistik Bio closed a $120 million Series B to advance a pipeline of small molecules targeting bleeding disorders and hematologic malignancies. The Cambridge, Massachusetts‑based biotech will use...
Orum banks $100M — degrader payloads meet antibody targeting
Orum Therapeutics secured about $100 million (146 billion KRW) to advance a platform that couples antibody targeting with protein‑degrading payloads—so‑called degrader‑antibody conjugates. The...
Chai Discovery raises $130M: AI antibody design moves to scale
Chai Discovery closed a $130 million Series B to expand its Chai‑2 AI platform for de novo antibody design. The company reported large‑scale preprint benchmarks showing double‑digit success rates...
Addition emerges with novel RNA 'jumping gene' tech — big funding
Addition Therapeutics unveiled its PRINT platform and disclosed major financing to develop an all‑RNA, lipid nanoparticle‑based gene insertion technology derived from retrotransposon biology. The...
Liver mRNA reprogramming restores aged T cells — transient fix
Two independent reports show transient hepatic expression of key trophic factors via mRNA delivery can rejuvenate aged T cell populations and enhance vaccine and cancer immunotherapy responses in...
Personalis’ ctDNA MRD test predicts immunotherapy response across tumors
A Phase I study published in Clinical Cancer Research found that Personalis’ tumor‑informed whole‑genome ctDNA assay (NeXT Personal) predicts immunotherapy outcomes across metastatic solid tumors....
FDA eases RWE rules: devices first, drugs to follow
The U.S. Food and Drug Administration signaled a less restrictive stance on real‑world evidence (RWE) by issuing guidance that premarket device applications need not include identifiable...
Moderna taps CEPI to prop up H5 pandemic‑flu Phase 3
Moderna secured backing from the Coalition for Epidemic Preparedness Innovations (CEPI) to underwrite its Phase 3 study of an H5 pandemic influenza vaccine after U.S. government support was...
FDA clears GSK twice‑yearly asthma shot — Exdensur approved
The U.S. Food and Drug Administration approved GSK’s depemokimab (brand name Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval...
Peanut patch wins pivotal test: DBV plans U.S. filing after Phase III
DBV Technologies reported positive top‑line results from its pivotal Phase III Vitesse trial of the Viaskin peanut patch in children aged 4–7. The trial met its primary endpoint: 46.6% of treated...
Addition emerges from stealth — $106M for RNA ‘jumping‑gene’ therapies
Addition Therapeutics announced a $106.5 million financing and detailed its Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform, an all‑RNA, lipid nanoparticle‑based approach to insert...
Orum pockets $100M — antibody‑degrader conjugates target AML
Orum Therapeutics closed about $100 million to advance a pipeline that fuses antibody targeting with protein‑degrader payloads. The company is pivoting toward ORM‑1153, a CD123‑targeting...
Chai Discovery raises $130M to scale AI antibody design
Chai Discovery closed a $130 million Series B to commercialize Chai‑2, its generative AI platform for de novo antibody design. The company published preprints showing multi‑target successes and...
Harbour Biomed inks BMS pact — up to $1.1B for multispecific antibody programs
Harbour Biomed signed a multiyear collaboration with Bristol Myers Squibb that includes roughly $90 million up front and potential milestones exceeding $1 billion to discover and develop...
ctDNA dynamics predict immunotherapy response; lymph fluid shows MRD promise
Two separate studies strengthened circulating‑tumor‑DNA (ctDNA) as a clinical biomarker. A Phase I study using Personalis’ NeXT Personal MRD assay found that early declines in tumor‑informed ctDNA...
FDA signals looser standards for real‑world evidence in reviews
The FDA announced a policy shift Dec. 15 to ease requirements for real‑world evidence (RWE) used in device premarket applications — specifically, the agency will not require identifiable...
CDC pivots on hepatitis B birth dose — universal guidance replaced with individualized approach
The U.S. Centers for Disease Control and Prevention adopted new Advisory Committee on Immunization Practices recommendations that end the universal hepatitis B birth‑dose policy that had been in...
Link Cell raises $60M — J&J backs CAR‑T spinout focused on solid tumors
Link Cell Therapies launched with a $60 million Series A to develop next‑generation CAR‑T therapeutics against solid tumors and announced strategic backing tied to Johnson & Johnson. The startup...