The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.
The U.S. FDA in 2018 granted the de novo petition by Seattle-based Adaptive Biotechnologies Corp. for the company’s DNA test for evaluation of residual hematological malignancies, but waited until March 8, 2025, to post notice of the attendant regulation.
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.
Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution.
U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies.
The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. So far, however, it has been injectables leading the way to approval.
Nutshell Therapeutics (Shanghai) Co. Ltd. has received IND clearance from the FDA to initiate a phase I trial in the U.S. with NTS-071 for anticipated use in solid tumors with a p53 Y220C mutation. The trial is expected to begin in the second half of this year.
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