It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rise 39% to close Feb. 2 at $4.10 on news the U.S. FDA has declined – for now – to approve the NDA for Anaphylm (dibutepinephrine), delaying the commercial entry of what could be the first oral alternative to Epipen. Read More
An AI-based software developed by Screenpoint Medical BV could help detect breast cancers earlier and reduce the number of cancers that appear between routine screenings. In a trial of over 100,000 women, the use of the company’s Transpara Detection system resulted in a 12% reduction in the rate of interval cancers, compared to standard mammography screening. The results from the Mammography Screening with Artificial Intelligence study was published in the Lancet.
More than four years after a phase II/III trial with Sanofi SA’s oral glucosylceramide synthase inhibitor venglustat was stopped for lack of benefit in autosomal dominant polycystic kidney disease, the company rolled out mixed phase III data from two more efforts. Read More
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes. Read More
An Anglo-American team of researchers has devised a new computational method for quantifying Epstein-Barr virus (EBV) directly from human genome sequences and used this to identify 22 genes that link higher levels of the virus to a range of chronic diseases. The new method sets the scene for further exploration of biobank DNA sequence data to gain greater understanding of the nature and the role of the human virome, the 10(13) – largely unstudied – viral particles that coexist in humans. Read More
Beginning Feb. 2, 2026, medical technology news and analysis will be integrated into BioWorld, where curated coverage will continue as part of BioWorld’s core reporting. Read More
The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S. Read More
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis. Read More
As the march toward a new therapy continues in metabolic dysfunction-associated steatohepatitis (MASH), new approaches are drawing Wall Street’s attention. Among them is Inventiva SA’s pan-PPAR approach. Read More
Liver fibrosis in the course of metabolic dysfunction-associated steatohepatitis could be significantly reduced using CAR T-cells generated in vivo. Scientists at the Icahn School of Medicine at Mount Sinai have developed an experimental cell therapy that eliminates only one type of liver cell, the stellate cells that express fibroblast activation protein alpha. This strategy not only reduced fibrosis but also reversed liver damage. Read More
BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October. Read More
Biopharmas raising money in public or private financings, including: Agomab, Altimmune, ALX, Biomarin, Coya, Lexicon, Promis, Spyglass, Vaxcyte. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Alps, Amgen, Astrazeneca, Bayer, IO Biotech, Kyowa, Moderna, Poxel, Recordati, Regeneron, Samsung Bioepsis. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Chiesi, Eli Lilly, Johnson & Johnson, Protalix, Sanofi, Ultragenyx, Unicycive. Read More
