FDA Newsfeed

… authorization (DEN250015) clearance from the FDA to begin marketing and sales … system. The device is currently: • FDA Cleared for USA. • Licensed by …

… on its website.  The FDA recently faulted AstraZeneca for an … cardiovascular death.” However, the FDA claimed that its approval of … ,” Adejuwon and Shah wrote. “FDA requests that AstraZeneca take immediate … Since September 9, the FDA has released 53 letters of …

… Rockville, MD 20852 RE: FDA Petition To Require Updated Pregnancy … the Food and Drug Administration (FDA) — pursuant to the Federal … , the petition asks the FDA to require new drug application … many other petitions to the FDA, this petition is grounded …

… more frequent engagement with the FDA as well as eligibility for … approval and priority review. “The FDA’s Fast Track designation is … 1. ITM receives U.S. FDA fast track designation for ITM … /itm-receives-u-s-fda-fast-track-designation-for-itm …

… significant milestones: Arctx was granted FDA 510(k) clearance to … (IDE) approval by the FDA to conduct CHILL-AP at … Arctx has now also received FDA marketing authorization for the Arctx … /arctx-medical-receives-fda-marketing-authorization-for-its-arctx …

… .S. Food and Drug Administration (FDA) urging the agency to require … . The petition calls on the FDA to require companies that market … the views expressed at the FDA’s July 21, 2025, Expert … many other petitions to the FDA, this petition is grounded in …

… their recent declines after the FDA added a warning label to … also excluded from treatment. The FDA is also requiring Sarepta to … ;We want to thank the FDA for their thorough and collaborative …

… US Food and Drug Administration (FDA) has accepted a supplemental New … is currently approved by the FDA for the treatment of plaque …

… US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe … 2026. In March 2025, the FDA granted 510(k) clearance to …

… Food and Drugs Authority (Rwanda FDA) and a local businesswoman who … , 2025, RIB said the Rwanda FDA inspector is under investigation for …

… liver failure following treatment. The FDA also limited use to patients …

Royal Philips has received FDA clearance for the latest version …

… an article authored by FDA Commissioner Marty Makary and … be viewed favorably. The FDA will also evaluate sustained improvement … to the article, the FDA will move forward with generating … detect safety signals.  The FDA’s innovative plausible mechanism pathway …

… Food and Drug Administration (FDA) is tightening restrictions on a … long been controversial at the FDA. For years, agency leaders … agency officials intervened. The FDA has told doctors they should … Elevidys should know the FDA has restricted who can …

… Food and Drug Administration (FDA) has taken the significant step … black box warning is the FDA’s most serious caution, … of the change, including FDA Commissioner Makary, argue that HT … estrogen-containing products, the FDA is keeping one crucial warning …

By Gianna Ferrarin ( November 17, 2025, 9:46 AM EST) -- The U.S. Supreme Court on Monday said it would not consider whether federal drug regulators went astray in denying fast-track review for a digestive disorder medication being developed by Vanda …

… cancer Designation provides increased FDA engagement, rolling review eligibility … Food and Drug Administration (FDA) has granted Fast Track … increased access to the FDA through more frequent communications … cellular function. The FDA recently opened the company …

The FDA has granted Fast Track … track designation follows the recent FDA clearance of Allterum’s investigational … in the news release. “The FDA’s fast track designation for … with leukemia: Allterum Therapeutics receives FDA fast track designation for 4A10 …

… Food and Drug Administration, FDA, to disclose records … any communications between the FDA and anti-abortion organizations … Trump administration officials, including FDA Commissioner Marty Makary, have … recent decision prohibits the FDA from ignoring the wealth …

… to be growing frustration about FDA Commissioner Marty Makary’s … large leadership changes at the FDA. Makary will have the … , who added that the FDA chief also expressed frustration at … confidence” in the HHS and FDA, noting that “Commissioner Makary’ …

The FDA on Friday adjusted the label … . The black box warning—the FDA’s most serious safety signal … from the safety updates, the FDA also required Sarepta to run … that it proposed to the FDA to add a boxed warning …

… announced today that it received FDA 510(k) clearance to expand … cord injury (SCI). Onward won FDA approval for the system in … including home use. Previously, the FDA cleared ARC-EX for use …

… drug application (IND) to the FDA for a Phase 1 clinical … ) SPC-15 trial subsequent to FDA approval. “We believe that a … categories which should meet the FDA’s clinical trial standards.” Data … . Silo intends to pursue the FDA’s 505(b)(2) accelerated …