The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations. Read More

Generate Biomedicines Inc. proved that enthusiasm hasn’t waned for TSLP as a target by pricing an IPO selling 25 million shares at $16 each for proceeds of $400 million. Generate’s lead compound is phase III-stage TSLP-targeting antibody GB-0895 and the company’s assigned Nasdaq ticker is GENB. The offering is expected to close on March 2. Read More

Targeting rare cardiomyopathy conditions with no approved disease-modifying therapies, Atrium Therapeutics Inc. started operations in San Diego, assuming the public listing and technology once held by Avidity Biosciences Inc., an RNA company acquired by Novartis AG for about $12 billion. Novartis closed the M&A, announced last October, as Atrium unveiled its pipeline and a $270 million cash position. Read More

At Biocom’s Global Partnering and Investor Conference, representatives from the business development departments at various pharmaceutical companies provided an update on their appetites for deals. The mood was fairly upbeat because, let’s face it, large pharma has become dependent on external development. Read More

In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer. Read More

U.S. med-tech companies are optimistic about the year ahead and believe that they are well positioned to navigate geopolitical headwinds and the uncertainty that they bring. Their technologies, which span neurosurgery and tissue reconstruction to cardiology and radiation protection, address important clinical needs. With the major U.S. corporates accelerating dealmaking and acquisitions, these companies see strong momentum building for the year ahead. Read More

The massive cuts to science, global health, and HIV programs that unfolded in 2025 triggered a crisis with worldwide repercussions. The dissolution of USAID, the shutdown of PEPFAR, and the suspension of thousands of NIH research projects led to an immediate collapse of essential services, from HIV prevention to access to treatment. At the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) held Feb. 22-25, 2026, in Denver, scientists, activists, and health professionals presented data illustrating the scale of the damage and warned of a historic setback in the global HIV response. Read More

The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19. Read More

Total raised in public, private and other financings of biopharma companies, comparing 2019-2026. 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 and med-tech industries, including: Akari, Impedimed, Insitro, Juvenescence, Kymera, Quest, Soleno, Xspray. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Avisi, Brainstorm, Clee, Compass, Larimar, Palvella, Vir. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Aicuris, Argenx, Argo, Ataibeckley, BMS, Eli Lilly, Endra, Gilead, GSK, GT Medical, Merck, Pfizer, PMV, Shionogi, Sumitomo, Systimmune, Viiv. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Arima, Beam, Biomerica, Blue Arbor, Boehringer, Celyn, Exthera, Gentuity, GE, Forj, IDT, Irlab, Jazz, Kairos, Neuwave, Ottobock, Quantum, Sitryx, Sciometrix, SK, Sumitomo, Thermo Fisher, Tevogen, Vaxxas, Viatris, Vocxi. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 4Web, Catalyst, Eton, Femasys, GSK, Ionis, Qure.ai, Soligenix, Vera, Viridian. Read More