The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of Moderna Inc.’s trivalent mRNA flu vaccine, mRNA-1010, which the company wants to brand as Mflusiva. On the question of whether the benefits of the product outweigh the risks in people ages 50 to 64, balloting was 9-0, and on whether the same is true in those 65 and older, the tally was again 9-0. Read More
Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy. Read More
Four years after the U.S. FDA issued a complete response letter for Spero Therapeutics Inc.’s oral antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin. Read More
J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. Read More
Schizophrenia (SZ), bipolar disorder (BP), major depression (MDD) and autism spectrum disorder (ASD) are serious mental illnesses (SMIs) that affect a significant proportion of the worldwide population. Large genome-wide association studies have pointed to overlapping genetics including both common and rare variants as cause of these SMIs. A recent study published on June 16, 2026, in Genomic Psychiatry has shed some light regarding the etiology of SMIs. Read More
Cardiovascular-focused Kardigan Inc. is the latest biopharma firm to take advantage of the wide open IPO window, pricing an upsized offering of 25 million shares at $16 per share, the high end of its proposed range, to rake in gross proceeds of about $400 million. Read More
Med-tech M&A value through the first five months of 2026 reached $62.98 billion, the highest total for the period since 2022’s $84.13 billion and a dramatic step up from 2025’s $22.4 billion and 2024’s $21.86 billion over the same stretch. Read More
Details were scant, but Biogen Inc. snagged a portfolio of early stage immunology-focused candidates by way of an acquisition deal for Raythera Inc. that could total as much as $1 billion. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Adaptive, Airs, Bioaffinity, Chugai, Dyne, Gero, Neogenomics, Roche, Sophia, Triveni, Vedana, Wise. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Arvinas, Assertio, Bayer, Bpgbio, GuideAI, Insight Molecular, Livanova, Perfuse, Pfizer, Rigel, Zydus. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Fibersense, Sernova, Uniqure, Vygon, Xaga. Read More
