ADARx Files For IPO To Fund Three Clinical siRNA Programs, Extending 2026 Biotech Listing Run
Michael Torres · Sep 7, 2026
Latest
MassBio And SCbio Select 10 Startups For Drive, Extending Early-Stage Support To Capital-Starved Founders
Jonathan Blake · Sep 6, 2026
Tactical Athletes Get New Cardiovascular Guidance, Expanding Care Standards Across 4 Million Workers
Emily Carter · Sep 5, 2026
Novartis Reports Pelacarsen Phase 3 Miss In 8,323 Patients, Leaving Lp(a) Field Open
Michael Torres · Sep 5, 2026
Across the beats
- AI in Drug Discovery
Generate Biomedicines’ GB-0895 Posters Leak Two Weeks Early, Exposing New Phase 1 COPD And Asthma Data
Dr. Alex Morgan Aug 27, 2026 - Biopharmaceutical Industry
Menarini Signs €664 Million Bofanglutide Deal, Giving Gan & Lee A 39-Country European Route
Michael Torres Sep 4, 2026 - Biotech Innovation
eGenesis Reports Two Pig Kidney Recipients Later Received Human Donor Organs, Easing A Key Xenotransplant Concern
Daniel Cho Sep 4, 2026 - Healthcare Investment
Truist Says Biotech Rebound Reached $136 Billion In Deals, As Financing And FDA Risks Ease
Daniel Cho Sep 4, 2026 - Medical Technology
Medtronic Recalls Bravo CF Capsule Delivery Devices After 184 Serious Injuries, Reviving A Prior Failure Mode
Daniel Cho Sep 2, 2026 - Regulatory & Policy
STAT Reports Lindsay Clancy Case Highlights Fragmented U.S. Care And Postpartum Coordination Gaps
Daniel Cho Sep 4, 2026
Most read
Novartis And Bristol Myers Halt Autoimmune CAR-T Studies After Immune Events, Pressuring A Fast-Moving CD19 Field
Sep 1, 2026
Novartis Signs Up To $3.2 Billion Alteogen Deal, Expanding Its Subcutaneous Delivery Options
Sep 2, 2026
Takeda And Protagonist Win Mimrylo Approval In Polycythemia Vera, Opening A Broader-Than-Expected Launch
Sep 1, 2026
Nature Papers Detail Two Prime Editing Routes For Large DNA Insertions Without Double-Strand Breaks
Aug 29, 2026
More coverage
Invivyd Names Marc Elia CEO Ahead Of VYD2311 Phase 3 COVID Readout
Invivyd said Elia, a board member since 2022 and current chairman, will now hold both chairman and CEO roles. The leadership change comes as the company prepares for top-line data from a phase 3 study of VYD2311 in adults and adolescents.
Jonathan BlakeSep 4, 2026
Regulatory & PolicyFDA Opens TEMPO Pilot To Four Generative AI Devices, Creating A Limited Early-Market Path
The TEMPO pilot gives digital health companies including Cadence and Limbic a route to put products in patients’ hands before formal authorization. For the Food and Drug Administration, the program creates a real-world testing ground for regulating care-influencing generative AI tools while supporting a payment experiment in chronic disease management.
Sophia ReynoldsSep 4, 2026
Biopharmaceutical IndustryIonis Wins FDA Approval For Zanvastro In Alexander Disease, Opening Its First Independent Neurology Launch
Zanvastro, formerly zilganersen, is an antisense oligonucleotide that lowers production of GFAP, the protein that accumulates in Alexander disease. For Ionis, the approval adds a commercial foothold in neurology as it prepares other RNA-based programs, including its Phase 3 effort in Angelman syndrome.
Emily CarterSep 4, 2026
Regulatory & PolicyARPA-H Commits Up To $125M For GIVE RNA Manufacturing Network, Backing Distributed Personalized Production
The program is aimed at replacing a centralized manufacturing model with faster, more accessible production for personalized RNA therapies. Early work will focus on cancer, rare genetic conditions and chronic diseases, with several biotech and academic teams assigned distinct manufacturing and quality-control roles.
Michael TorresSep 3, 2026
Biopharmaceutical IndustryPfizer Transfers PF-08046031 To Medicus In Up To $1B-Plus Deal, Extending Seagen Asset Recycling
Medicus will pay $12 million upfront and another $15 million on Sept. 2, 2027, according to an SEC filing, while Pfizer also contributed $2 million to support the program. The transaction shows how large acquirers can keep economic exposure to discontinued assets without carrying full development costs.
Daniel ChoSep 3, 2026
Biopharmaceutical IndustryGSK Bets Up To $1.295 Billion On Hutchmed’s HMPL-A830, Extending Its Asia Deal Push
GSK has licensed worldwide rights to HMPL-A830 outside mainland China, Hong Kong, Macau and Taiwan, where Hutchmed retains control. Initial development will focus on colorectal, pancreatic and lung cancers, with Hutchmed running Phase 1 before GSK takes over later-stage development and commercialization.
Daniel ChoSep 3, 2026
Biotech InnovationUltragenyx Misses Phase 3 Aspire In Angelman Syndrome, Prompting Expense Reduction Review
The setback follows Ultragenyx’s recent approval for Genglycos and arrives just weeks before a PDUFA date for UX111 in Sanfilipo syndrome. The failed study also raises commercial and development questions for apazunersen beyond this single trial.
Daniel ChoSep 3, 2026
Regulatory & PolicyFDA Raises Foreign Trial Scrutiny, Tightening Standards As China Research Expands
Four FDA officials used an FDA Voices editorial to signal stricter oversight of foreign trial sites, including more resources for inspections, added reviewer training and earlier discussions with sponsors about foreign data provenance. The policy message is broader than any one country, but it arrives amid rising concern about data integrity and human subject protections as trial activity in China has expanded.
Dr. Alex MorganSep 3, 2026
Biotech InnovationTeva Reports Phase 2a TEV ’408 Win In Celiac Disease, Extending Its IL-15 Bet
In the 50-patient study, adults with celiac disease received TEV ’408 or placebo before a six-week daily gluten challenge. Teva said the antibody significantly reduced intestinal damage versus placebo and reported no safety signals, while signaling that additional phase 2 work is needed before a phase 3 program can proceed.
Dr. Priya NandakumarSep 3, 2026
Biopharmaceutical IndustryFortrea Buys Worldwide Early-Phase Unit For $45 Million, Expanding Texas Capacity
Fortrea said the acquisition will bring Worldwide’s clinical pharmacology unit and bioanalytical laboratory operations into its clinical pharmacology services business unit. The transaction is aimed at adding early-phase capacity and reducing handoffs between clinical and bioanalytical functions, while Worldwide plans to use the proceeds to support its late-stage focus areas.
Dr. Priya NandakumarSep 3, 2026
Regulatory & PolicyUniQure Files AMT-130 For FDA And U.K. Review, Reopening A Huntington’s Gene Therapy Path After FDA Reversal
The applications put AMT-130 on track to become the first genetic treatment for Huntington’s disease if regulators agree that three-year Phase 1/2 data can support accelerated approval. The bigger signal is regulatory: the case tests how far the FDA will go in accepting external controls and small-population gene therapy data after a public dispute inside the agency earlier this year.
Emily CarterSep 2, 2026
Regulatory & PolicySEC And FDA Sign Three-Year Information-Sharing Pact, Tightening Biopharma Insider Trading Scrutiny
The pact does not create entirely new SEC powers, but it gives both agencies a more formal mechanism to exchange non-public information and route requests through designated points of contact. For biopharma companies, the practical implication is a tighter link between what is said to investors and what the FDA may know about clinical trials, approvals, and other regulated events.
Dr. Priya NandakumarSep 2, 2026