Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes. Read More

The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking. Read More

Beijing QL Biopharmaceutical Co. Ltd.’s once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met its primary and secondary endpoints in a phase II obesity trial, and QL Biopharm will now advance the GLP-1 to a pivotal phase III study. Read More

Renewing hopes of restoring the rare pediatric disease priority review voucher (RPD PRV) program that expired at the end of 2024, the House Energy and Commerce Committee voted 47-0 Sept. 17 to advance the Give Kids a Chance Act of 2025 (H.R. 1262), one of six pieces of legislation slated to move to the full U.S. House for consideration. Read More

Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price. Read More

The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159. Read More

Two back-to-back papers published in Nature on Sept. 10, 2025, shed new light on the unexpected role of neurons in shaping the evolution of small-cell lung cancer (SCLC). It’s already known that, in gliomas, cerebral cancer cells actively damage axons, contributing to tumor progression through direct neural disruption. Comparable nerve-tumor interactions have been reported in peripheral cancers, where tumor-induced nerve disruption promotes inflammation and an immunosuppressive microenvironment linked to immunotherapy resistance. Read More

Total raised in public, private and other financings of biopharma companies, comparing 2019-2025. Read More

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

New hires and promotions in the biopharma industry, including: Epitopea, Flagship, Mink, Neumirna, Vaxart. Read More

Biopharmas raising money in public or private financings, including: Biocardia, Daiichi, Immuto, Medicus, Mondego. Read More

Clinical updates, including data readouts and publications: Almirall, Astrazeneca, Carsgen, Contineum, Corestemchemon, Eli Lilly, Geneos, Kairos, Leo, Lipella, MagicRNA, Nanobiotix, Nektar, Novo Nordisk, PDS, QL. Read More

Biopharma happenings, including deals and partnerships, and other news in brief: Arvinas, Alcyone, Austrianova, Avant, Biocardia, Biogen, Bluebird, Genetix, Klothonova, Infinimmune, Immunome, Novo Nordisk Pfizer, X4. Read More

Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Astrazeneca, Biogen, Curatis, Deciphera, J&D, Minovia, Replimune. Read More