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FDA eases RWE bar for devices: lower need for patient‑level records
The U.S. Food and Drug Administration said it will take a less restrictive approach to real‑world evidence for device premarket applications, allowing sponsors to use large datasets that lack...
Biosecure Act edges toward law: supply‑chain and data curbs loom
Legislation modeled in the Biosecure Act advanced in the 2026 National Defense Authorization Act, putting a congressional structure in place to bar certain federal funds from flowing to foreign...
FDA greenlights GSK’s depemokimab: long‑acting add‑on for asthma
The FDA approved depemokimab, an anti‑inflammatory biologic from GSK, as an add‑on treatment for patients aged 12 and older with certain severe asthma indications. GSK projects peak sales in the...
Immunome’s oral gamma‑secretase succeeds: Phase III win, NDA planned
Immunome reported positive top‑line Phase III results for its oral gamma‑secretase inhibitor, varegacestat, in progressing desmoid tumors — showing an 84% reduction in risk of progression or death...
XOMA Royalty to acquire Generation Bio: adds ctLNP and Moderna royalties
XOMA Royalty announced an agreement to acquire Generation Bio, a developer of cell‑targeted lipid nanoparticle (ctLNP) delivery technology, in a cash tender offer valued at about $4.29 per share...
Chai raises $130M Series B — AI antibody designer hits $1.3B valuation
Chai Discovery closed a $130 million Series B to accelerate development of its Chai‑2 generative platform for de novo antibody design and to expand commercialization, the company announced. The...
Immunome’s oral drug slashes progression risk — Phase 3 win in desmoid tumors
Immunome reported positive top‑line Phase 3 results for its oral gamma‑secretase inhibitor, which reduced the risk of disease progression or death by 84% versus placebo in patients with...
Kyverna to seek FDA clearance — autoimmune CAR‑T posts pivotal gains in stiff person syndrome
Kyverna Therapeutics said its patient‑specific CAR‑T therapy produced clinically meaningful improvements in mobility and stiffness in a registrational trial for stiff person syndrome, meeting the...
GSK wins FDA nod for long‑acting asthma drug — depemokimab cleared
GSK secured U.S. Food and Drug Administration approval for depemokimab as an add‑on treatment for patients aged 12 and older with certain inflammatory asthma indications, the company announced....
Yarrow inks $1.37B GenSci deal — buys ex‑China rights to TSHR antibody
Yarrow Bioscience, backed by RTW Investments, struck an ex‑China licensing and development agreement with Shanghai Scizeng Medical Technology (GenSci) for GS‑098 (YB‑101), a TSHR‑targeting...
Adaptive licenses TCR tech to Pfizer — multi‑year pact could top $890M
Adaptive Biotechnologies said it entered two agreements with Pfizer granting access to Adaptive’s immune‑receptor discovery platform and TCR‑antigen mapping data. One is a collaboration to...
Tumor‑selective mRNA: engineered SMRTS toggles cell‑selective gene expression
Researchers reported a tumor‑selective mRNA system (SMRTS) that programs modified mRNA to activate therapeutic genes selectively in cancer cells while shutting off expression in healthy cells,...
XOMA to acquire Generation Bio — royalty aggregator buys ctLNP delivery platform
XOMA Royalty announced an agreement to acquire Generation Bio in a cash tender offer and contingent value right structure, positioning XOMA to capture potential milestone and royalty streams tied...
CDC ends universal newborn hepatitis B guidance — major immunization policy shift
The U.S. Centers for Disease Control and Prevention announced it will end its longstanding guidance that all newborns should receive the hepatitis B vaccine, marking a substantial change in...
Sanofi’s MS bet falters — tolebrutinib Phase 3 misses primary endpoint
Sanofi reported that tolebrutinib, its BTK inhibitor acquired in a prior buyout, failed to meet the primary endpoint in the phase III Perseus trial for primary progressive multiple sclerosis, the...
Immunome’s phase‑3 win slashes desmoid progression — NDA next
Immunome reported positive topline results from a registrational Phase 3 trial showing its oral gamma‑secretase inhibitor (varegacestat) reduced risk of disease progression or death by 84% in...
Sanofi snaps up ADEL’s tau antibody: $1.04B licensing pact
Sanofi agreed to license ADEL’s tau‑targeting antibody ADEL‑Y01 in a deal worth up to $1.04 billion, including an $80 million up‑front payment, ADEL and Sanofi disclosed. The agreement grants...
Chai Discovery raises $130M — AI antibody design goes mainstream
Chai Discovery closed a $130 million Series B at a reported $1.3 billion valuation to expand its AI‑driven de novo antibody platform, the company announced. The round — led by Oak HC/FT and...
Radiopharm’s RAD‑101 PET tracer hits imaging endpoints in brain mets trial
Radiopharm Theranostics reported interim Phase IIb imaging results showing RAD‑101 (F18‑Pivalate) met its primary endpoint, achieving concordance with MRI in 92% of treated brain metastasis...
Droplet validates postoperative lymph fluid for MRD detection in head and neck cancer
Droplet Biosciences and academic collaborators published validation data showing postoperative lymph fluid can detect circulating tumor DNA (ctDNA) with higher sensitivity than matched early...