U.S. federal agency that regulates the safety and approval of drugs, biologics, medical devices, vaccines, food, and tobacco products.
Viatris is buying Pacira BioSciences for $1.65 billion to grow its pain-management business. At about 9.3 times Pacira's adjusted EBITDA the deal adds earnings at once, but the growth case waits on a December FDA ruling on Viatris's own fast-acting meloxicam.
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Regeneron's Otarmeni won FDA approval in April as the first gene therapy for hearing loss, with 42 percent of 24 treated children since regaining hearing. The deafness it treats leaves the rest of the ear intact. How far the approach can reach beyond this one gene is still unknown.
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Rare-disease specialists told Live Science that wide genetic testing could diagnose most rare diseases, since about 80% of them are genetic in origin. That share counts diseases, not patients, so it sets a ceiling on what sequencing can reach for the people still searching.
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Homeland Security plans to have Google's AI propose redactions on 100,000 to 140,000 FOIA requests by the end of September. Officers will review the suggestions, but the plan's stated payoff is faster processing, a measure that cannot show text blacked out in error.
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The Ray-Ban Meta Audio pair runs the same Muse assistant as the Gen 3 flagship and drops the image capture that Mark Zuckerberg named first when he explained why glasses beat every other AI wearable.
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A questionnaire sent to bison producers across the southern and central United States found treatment set mostly by the calendar, and the veterinary parasitologists who ran it are worried about what that does to a short list of drugs.
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The FDA is investigating whether GLP-1 drugs cause sudden vision loss, and the New Jersey filings number in the dozens. The market those drugs sell into is projected at $92 billion this year.
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Wandercraft's Eve is cleared for adults with spinal cord injuries at any level who can work its controller. Getting one starts with a provider's prescription, a custom fitting, and a coverage decision on each individual claim.
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Telix is buying privately held ITM in a merger STAT puts at a minimum of $1.65 billion, with another $700 million payable only if ITM's lead drug clears regulators and meets sales goals. STAT says the deal follows a surprise FDA rejection.
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More than 90 New Jersey suits and dozens more against Novo Nordisk and Eli Lilly turn on a warning the FDA has not written while four other jurisdictions added theirs. Denmark's payouts are the only money that has moved so far.
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At the Children's Health Defense conference, the health secretary read adverse reactions off a hepatitis B package insert whose own text says their frequency and cause cannot be established. HHS now has more than 150 such reported events under study.
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Definium Therapeutics says more than 200 adults with moderate or severe generalised anxiety improved three months after a single dose of LSD, and a UCL researcher expects FDA approval within a year or two.
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Corologic's AngioFilm interpolates low-frame-rate coronary angiography video in real time so the machine takes fewer X-ray pictures, and the seed money from Kakao Ventures and SNU Holdings is going to multicenter validation and approvals.
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Kiwoom Securities says the FDA has suspended new enrollment in one of two registrational trials of the epilepsy drug SK Biopharmaceuticals agreed to license from Biohaven last month, and the closing payment is still outstanding.
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Azetukalner beat placebo by 42.8 points at the Phase 3 high dose and the FDA filing is due this quarter, yet a Seeking Alpha analyst values Xenon at $62 against a $59 price and rates it a Hold.
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A peer-reviewed count from the Food Packaging Forum Foundation puts 1,222 of 15,159 food-contact chemicals in serious hazard categories and finds 13,211 with no harmonized data at all. That leaves a denominator of 1,948.
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The FDA said in May it would not act against some unauthorized flavored vapes whose applications are pending. Reynolds American is now testing, in a suburban Ohio retail aisle, what that forbearance is worth.
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Revolution Medicines' expanded access program for Rasonque closed immediately on FDA approval, leaving patients still mid-application to wait on insurers whose paperwork moves slower than metastatic pancreatic cancer.
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Moderna's melanoma readout and an FDA approval a week later gave biotech bulls their summer story, though the figure worth underwriting is the calendar behind the RAS drug: money raised in 2012, asset sold in 2018, approval fourteen years on.
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Age verification built into the hardware has now passed FDA review as part of a product, which hands later applicants a template, though the lock Juul will ship is switched on at the owner's option.
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