A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.
CMR Surgical Ltd.’s participation in Nvidia’s Physical AI health care robotics initiative is expected to accelerate the development of the next generation of intelligent surgical robotic systems powered by data, simulation and AI. As demand for minimally invasive procedures grows, more companies are entering the surgical robotics space.
What one analyst called an “intriguing” overall survival signal in phase III results has Karyopharm Therapeutics Inc. planning to meet with the U.S. FDA about a would-be sNDA filing for Xpovio (selinexor) in myelofibrosis (MF).
For a company founded only four years ago, Quotient Therapeutics Inc. entered its third major deal, this time with Merck & Co. Inc. to find novel drug targets for inflammatory bowel disease (IBD) using its somatic genomics platform technology.
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
T-cell engager company Kali Therapeutics Inc. licensed its lead product, CD19/BCMA/CD3 trispecific antibody KT-501, to Sanofi SA in a global deal that could be worth more than $1.2 billion. The San Mateo, Calif.-based biotech first emerged in 2024 and moved KT-501 into a phase Ia trial last week to treat adults with rheumatoid arthritis.
In a competitive and still-needy space where Apogee Therapeutics Inc. CEO Michael Henderson noted that “even modestly differentiated products are quickly becoming blockbusters,” his firm’s IL-13 antibody zumilokibart (zumi, APG-777) has turned up satisfying phase II data in part A of the phase II atopic dermatitis (AD) experiment called Apex in moderate to severe disease. “We’re still digesting the data,” Henderson added, pointing out that the results proved better than Apogee expected at both time intervals tested.
Overall, results from the phase III Valor trial testing Lyme disease vaccine PF-07307405 “strengthen confidence” in the candidate, according to partners Pfizer Inc. and Valneva SE, with the big pharma now looking toward regulatory submissions. Investors, however, focused on the fact that the study, which demonstrated more than 70% efficacy in preventing Lyme disease in individuals, ages 5 and older, failed to hit the statistical criterion for the first prespecified analysis.
A member of the CDC’s Advisory Committee on Immunization Practices (ACIP), physician and biochemist Robert Malone, who a judge earlier this week suggested lacked vaccine-related experience, wrote March 19 on X that the committee “has been disbanded.” Nearly six hours later, he followed up, saying it was a “miscommunication.”
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when approvals reached 12 in January and 16 in February (28 total), early 2026 activity is consistent with historical ranges.
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