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FDA clears ziftomenib — first menin inhibitor for NPM1‑mutant AML
The U.S. Food and Drug Administration approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti), a selective oral menin inhibitor, for relapsed or refractory acute myeloid leukemia with NPM1...
Tessera to test gene writing in humans — in vivo program enters clinic
Tessera Therapeutics confirmed it will begin its first-in-human trial next month for an in vivo gene‑writing platform, targeting adults with a rare genetic disease (alpha‑related condition...
Genomic foundation models and semantic design reshape synthetic biology
Researchers announced two advances that move AI‑driven genomics toward practical design: BGI’s Genos, a human‑centric genomic foundation model trained on hundreds of near telomere‑to‑telomere...
Merck shells out for Cidara — big bet on long‑acting influenza prevention
Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD388, a late‑stage, long‑acting, strain‑agnostic antiviral designed to prevent symptomatic influenza in high‑risk...
Roche’s oral SERD delays recurrence — adjuvant win shakes breast‑cancer landscape
Roche/Genentech reported positive Phase III data from Lidera showing its oral selective estrogen receptor degrader giredestrant improved invasive disease‑free survival compared with standard...
First‑in‑class FcγRI blockers suppress autoimmune pathology in preclinical models
Scientists at UMC Utrecht reported two FcγRI‑specific antibodies (C01 and C04) that competitively block high‑affinity IgG binding to CD64 (FcγRI) and suppress autoimmune responses in preclinical...
AI biotech funding surges — Profluent and Iambic raise major rounds
Two AI‑focused biotechs announced large financing rounds this week: Profluent raised $106 million to accelerate its AI protein‑design platform and commercial deployments across therapeutics,...
Spatial multi‑omics alliance and tumor atlases boost translational cancer biology
Two separate spatial‑biology initiatives advanced this week: the Asia‑Pacific Spatial Translational Research Alliance (ASTRA), led by Garvan Institute and University of Tokyo, will use 10x...
Merck snaps up Cidara for $9.2B — Influenza prevention bet
Merck agreed to buy Cidara Therapeutics for $9.2 billion to add CD388, a long-acting, strain-agnostic influenza antiviral, to its respiratory portfolio. Cidara’s CD388 combines a neuraminidase...
J&J shells out $3.05B for Halda — Precision oncology scale-up
Johnson & Johnson agreed to acquire Halda Therapeutics for $3.05 billion in cash to expand its oncology pipeline with Halda’s precision oncology candidates, led by HLD‑0915 for metastatic...
Roche’s oral SERD wins pivotal adjuvant readout — breast cancer landscape shifts
Roche reported positive Phase III adjuvant results for its oral selective estrogen receptor degrader (SERD) giredestrant, showing a statistically significant improvement in invasive disease‑free...
Broad’s Liu unveils PERT prime‑editing platform — one agent, many diseases
Researchers in David Liu’s lab at the Broad Institute described a prime editing strategy called PERT (prime editing‑installed suppressor tRNAs) that converts endogenous tRNAs into suppressor RNAs...
Tessera to enter humans: Flagship’s gene writing platform hits clinic
Tessera Therapeutics announced it will start its first human trial next month, testing its in vivo gene writing platform in adults with a rare genetic disease (alpha‑related indication disclosed...
Arrowhead’s RNAi drug cleared — commercial launch and pricing battle begins
The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals’ RNAi therapy plozasiran (Redemplo) for familial chylomicronemia syndrome (FCS), making Arrowhead a commercial‑stage RNAi...
Profluent raises $106M — AI protein design draws Bezos, Altimeter
AI protein design company Profluent closed a $106 million financing led by Altimeter Capital and Bezos Expeditions to expand large‑scale models for protein design and commercialize bespoke...
Function Health raises $298M — retail lab testing scales to $2.5B valuation
Function Health closed a $298 million Series B led by Redpoint Ventures, valuing the company at $2.5 billion. The Austin‑based lab testing and imaging subscription startup offers consumers access...
Congressional push for a Biopharma Manufacturing Center of Excellence — bipartisan bill filed
A bipartisan group of senators and representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE) to accelerate domestic biomanufacturing...
Administration unrest clouds vaccines: industry alarm over policy shifts
Companies warned that proposals under the Trump administration and statements by Health Secretary Robert F. Kennedy Jr. could force major changes to vaccine formulations and schedules. Reporting...
J&J spends $3.05B to buy Halda – expands precision oncology bets
Johnson & Johnson agreed to acquire Halda Therapeutics for $3.05 billion in cash to add Halda’s precision oncology assets to its pipeline. The deal centers on HLD-0915, a clinical-stage prostate...
Merck buys Cidara for $9.2B – targets long-acting, strain-agnostic flu shot
Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD388, a long-acting, strain-agnostic influenza antiviral in Phase III. CD388 combines a neuraminidase-targeting small...