FDA
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
FEATURED STORIES
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Medtronic plc announced U.S. Food and Drug Administration clearance and commercial launch for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing.
The U.S. Food and Drug Administration approved Celgene’s Revlimid (lenalidomide) in combination with a rituximab product for adults with previously treated follicular lymphoma or marginal zone lymphoma. It is the first FDA-approved combination therapy for patients with these forms of non-Hodgkin’s lymphoma that doesn’t include chemotherapy.
There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.
The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
The approval of Jakafi marks the first approved treatment for this indication in the United States.
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
Sorilux was approved for the treatment of patients age 12 and up.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.