FDA

WASHINGTON — The Food and Drug Administration on Wednesday approved the drug Zevtera for the treatment of adults with certain bloodstream infections, those with acute bacterial skin and skin structure infections, and adult and pediatric patients 3 months to less... Read More

WASHINGTON — The Food and Drug Administration warned consumers on Tuesday not to use certain over-the-counter pain relief products marketed for topical use before, during or after certain cosmetic procedures. The warning came after the agency issued warning letters to... Read More

WASHINGTON — The Food and Drug Administration has unveiled a new website detailing the Foods Program regulations it plans to publish through October 2024. The web portal, which will also list longer-term regulations the agency is prioritizing for publication at... Read More

WASHINGTON — The Food and Drug Administration on Friday authorized Florida to purchase millions of dollars' worth of medications from Canada, a move long opposed by the pharmaceutical industry. The goal of the approval is to give states access to... Read More

WASHINGTON — A popular hypoallergenic infant formula has been voluntarily recalled by its manufacturer due to possible Cronobacter sakazakii contamination. The formula, Nutramigen Hypoallergenic Infant Formula Powder, is manufactured by Reckitt/Mead Johnson Nutrition. According to an alert issued by the... Read More

WASHINGTON — The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology for the treatment of sickle cell disease. The new treatment, called Casgevy, was manufactured by Vertex Pharmaceuticals, of Boston, Massachusetts, and... Read More

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs,... Read More

WASHINGTON — The Food and Drug Administration has approved the sale of the first over-the-counter antigen test for COVID-19. The product, ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home... Read More

WASHINGTON — The Food and Drug Administration is creating a new Digital Health Advisory Committee to help the agency assess and deal with the complex scientific and technical issues related to the burgeoning market of new digital health technologies. These... Read More

WASHINGTON — The Food and Drug Administration on Tuesday amended its emergency use authorization for the Novavax COVID-19 vaccine, approving an updated version of the vaccine for use by previously vaccinated individuals aged 12 and older. Of course, those who... Read More

WASHINGTON — The Food and Drug Administration has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing... Read More

WASHINGTON — A common decongestant ingredient used in many popular over-the-counter medications simply doesn’t work, an advisory panel to the Food and Drug Administration said Tuesday, potentially setting the stage for a sweeping removal of many cold and flu remedies... Read More

WASHINGTON — The Food and Drug Administration on Monday approved the use of updated COVID-19 vaccines to provide the public with additional protection against the virus ahead of a potential winter bump in cases. One thing the FDA did not... Read More

WASHINGTON — The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription in the United States.  The agency’s approval of the over-the-counter medication this morning is a first, and is seen as... Read More

WASHINGTON — The Food and Drug Administration on Friday published a new draft guidance on what researchers should consider when investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.  The first-of-its-kind... Read More

WASHINGTON — A panel of federal health advisors voted unanimously on Wednesday to approve the first over-the-counter sale of a medical contraceptive. The vote came at the end of a two-day meeting during which the panel, which offers nonbinding recommendations... Read More

WASHINGTON — The Food and Drug Administration on Tuesday issued an emergency use authorization for Gohibic (vilobelimab) injections to be used to treat COVID-19 in hospitalized adults. The authorization allows for the use of the injection within 48 hours of... Read More

MINNEAPOLIS (AP) — Minnesota Attorney General Keith Ellison is slated to lead off opening statements expected for Tuesday in his state's lawsuit against Juul Labs – marking the first time any of the thousands of cases against the e-cigarette maker... Read More

BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia, Karuna Therapeutics announced Monday that it is on track to submit KarXT to the Food and Drug Administration for approval... Read More

WASHINGTON — The Food and Drug Administration has amended its emergency use authorization of the Pfizer-BioNTech COVID-19 Bivalent vaccine, authorizing its use as a single booster dose for children 6 months through 4 years who’ve completed their primary vaccinations with... Read More

WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how the Food and Drug Administration approves and manages opioid medications. “In the last year, more than 106,000 Americans and 1,400... Read More

WASHINGTON — A panel of advisors to the Food and Drug Administration narrowly voted on Tuesday to endorse an experimental vaccine from Pfizer to protect older adults against the highly contagious lower respiratory tract ailment RSV. The advisors voted 7-4... Read More

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday. Mifepristone is the first of two... Read More

WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA... Read More

WASHINGTON — A panel of advisors to the Food and Drug Administration on Tuesday declined to recommend approval of a new heart drug created by biotech firm Cytokinetics, finding the benefits of the drug do not outweigh its risks. The... Read More

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old. “More children... Read More

WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in... Read More

WASHINGTON — The Food and Drug Administration has conditionally approved Panoquell-CA1 for the management of clinical signs associated with acute onset of pancreatitis in dogs.  Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment... Read More

WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.  Under the auspices of a memorandum of understanding signed last week, the... Read More

WASHINGTON (AP) — A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig’s disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The... Read More