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Latest Biotech News

ARPA-H grants to build FDA-authorized heart AI agents

September 09, 2026

ARPA-H selected UpDoc, Tempus AI and Atman Health for a new federal program designed to build FDA-authorized agentic AI tools to manage people with heart disease. The initiative, announced by the...

FDA leadership stability in drugs and biologics

September 09, 2026

HHS made permanent the acting heads of two FDA centers, with Michael Davis becoming permanent director of CDER and Karim Mikhail taking over CBER. The appointments also created a new deputy...

RNA drug development moves from target discovery to funding and IND pathways

September 09, 2026

RNAV8 Bio was selected for ARPA-H funding under PROPEL, a program aimed at building programmable RNA medicines with more controllable protein output and precise localization. The one-year pilot...

Cell therapy momentum in multiple myeloma

September 09, 2026

Bristol Myers Squibb notched a “key derisking event” in multiple myeloma with Phase 2 QUINTESSENTIAL results for arlocabtagene autoleucel (arlo-cel). Analysts said the data support positioning...

AI-designed drug signals biological age shifts in early IPF trial workups

September 09, 2026

Insilico Medicine’s AI-designed drug rentosertib showed exploratory signals of reduced biological age markers in a post-hoc analysis from a small idiopathic pulmonary fibrosis trial. Using six...

Precision oncology funding—Solstice bets on next-gen CTLA-4 immunotherapy

September 09, 2026

Solstice Oncology raised $225 million through a Series A to advance a next-generation CTLA-4 immunotherapy program built from Harbour BioMed technology. The company said it is targeting...

Diabetes R&D spinout tied to Lilly-backed menin inhibition

September 09, 2026

Kura Oncology spun out Caspian Therapeutics to take its menin inhibitor KO-7246 into early diabetes development, securing $50 million in financing led by BVF Partners with Eli Lilly participating....

Obesity pipeline financing for adipose-targeted RNAi

September 09, 2026

Moonwalk Biosciences raised $70 million in Series B financing to advance its adipose-targeted RNAi obesity candidate MW-101 into first-in-human trials. The company said it will use proceeds to...

Clinical trial signal setbacks in bladder cancer

September 09, 2026

Tyra Biosciences reported disappointing early Phase 2 bladder cancer results for dabogratinib (Surf302) in FGFR3-altered low-grade intermediate-risk non-muscle-invasive bladder cancer, with...

FDA leadership stability and regulatory continuity

September 09, 2026

The FDA moved to lock in continuity in two central regulatory divisions, promoting Michael Davis and Karim Mikhail from acting to permanent directors of CDER and CBER, respectively, according to...

Multiple myeloma CAR T expands as BMS posts Phase 2 win

September 09, 2026

Bristol Myers Squibb said its GPRC5D-directed CAR T arlocabtagene autoleucel delivered notable improvements in its QUINTESSENTIAL Phase 2 study for heavily pretreated relapsed and refractory...

Obesity pharma: Wegovy Phase 3 data for kids and new traction

September 09, 2026

Novo Nordisk reported that Wegovy helped free about 40% of children from obesity in a Phase 3 trial, according to the provided report. The outcome adds to the expanding pediatric obesity data set...

Biotech funding and platform momentum: Moonwalk advances adipose-targeted RNAi

September 09, 2026

Moonwalk Biosciences raised $70 million in Series B financing to advance its adipose-targeted RNAi obesity candidate MW-101 into the clinic. The company said it expects first-in-human dosing in...

AI-designed drug signals biological-age reversal in small IPF study

September 09, 2026

Insilico Medicine reported an exploratory analysis suggesting rentosertib—an AI-designed inhibitor being studied for idiopathic pulmonary fibrosis—reduced protein-based biological-age clock...

Diabetes pipeline spinout from Kura: Lilly-backed Caspian Therapeutics

September 09, 2026

Kura Oncology spun out Caspian Therapeutics to develop menin inhibitors for diabetes and cardiometabolic diseases. Caspian will initially focus on KO-7246, a small molecule intended to support...

Regulatory action in oncology: FDA clears AstraZeneca’s oral SERD for first-line breast cancer

September 09, 2026

The FDA granted accelerated approval to AstraZeneca’s oral SERD camizestrant (Etcamah) for first-line use in a defined breast cancer population, according to the report. The decision came after an...

Cell therapy trial success in bladder cancer: Tyra advances to pivotal work

September 09, 2026

Tyra Biosciences reported Phase 2 data for dabogratinib in bladder cancer and said it will advance toward a pivotal study. The report frames the dataset as a step toward challenging established...

Biosafety and quality spotlight: antibody image manipulation investigation

September 09, 2026

A report by Northwestern University’s Reese Richardson and colleagues found widespread photo editing in commercial antibody catalogs, implicating more than 15 companies and identifying nearly...

Biopharma development: disulfidptosis links to targets for cancer cell death

September 09, 2026

A new review in Medical Oncology summarizes emerging biology around disulfidptosis, a form of cancer cell death described as atypical compared with classical pathways. The article outlines...

FDA leadership stability

September 09, 2026

The HHS announced that acting leaders at the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will become permanent, aiming to restore...