The FDA approved labeling changes for six menopausal hormone therapy products, removing certain risk statements from the boxed warning. The agency said the action follows a literature review initiated in November 2025.
On February 12, 2026, the FDA approved Adquey (difamilast 1%) ointment from Acrotech Biopharma for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The commercial question centers on where difamilast can earn durable share against entrenched topicals. Mechanistically, difamilast
A phase III study of more than 2,000 patients found post-surgical ctDNA detection was associated with a four- to six-fold increase in recurrence risk, according to Guardant Health.
The FDA approved Novocure’s Optune Pax for adults with locally advanced pancreatic cancer through the PMA pathway. The decision was based on a randomized, controlled study with follow-up up to five years.
Series D backs global rollout of automated IDMO factories as Cellares targets lower costs, higher throughput, and commercial scale.
Affinia Therapeutics secured FDA acceptance of its AFTX-201 IND, enabling initiation of the Phase 1/2 UPBEAT study in BAG3-associated dilated cardiomyopathy with safety and tolerability as key endpoints.
ImmunityBio has launched a Phase 2 outpatient trial evaluating a chemotherapy-free combination of off-the-shelf CD19-targeted NK cells, ANKTIVA, and rituximab in relapsed or refractory indolent B-cell lymphomas.
February 12, 2026 is the expected record date for the spin-off of Atrium Therapeutics, which will hold Avidity's early-stage precision cardiology programs.
Piramal Pharma Solutions has commercialized a tablet-in-capsule drug delivery capability following a five-month technology transfer between its Ahmedabad development facility and its commercial manufacturing site in Pithampur, India.
AstraZeneca has shifted its U.S. listing to ordinary shares on the New York Stock Exchange as it targets $80 billion in annual revenue by 2030, alongside announcing major investment and licensing commitments in China.
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
With global oncology scale and nearly 2,000 scientific publications, Flatiron Health is positioning itself as the industry’s most trusted evidence partner by pairing AI-driven speed with uncompromising scientific rigor. “We don’t chase hype. We build trust, and in healthcare that’s non-negotiable.”
As Scipher expands from predictive diagnostics into drug development, CEO Reginald Seeto stresses that technology must drive real clinical decisions: ‘You’ve got to bring technology to the point of greatest impact - otherwise even great innovations never get progressed.’
Inhibrx has built its drug discovery engine around tight, focused teams. The philosophy is simple: “We’re best when we’re smaller. When teams get too big, they stop innovating,” shaping how programs are advanced or spun out.
For these patients, cough isn’t just a symptom - it rules their day. Trevi Therapeutics is targeting triggers in the lung as well as cough’s neurological roots,” says CEO Jennifer Good.
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
