FDA Newsfeed

… Food and Drug Administration (FDA) has granted Orphan Drug … novel therapeutic approaches. “The FDA’s decision to grant … the most widely used FDA-approved chemotherapy for pancreatic … quarter of 2025.” The FDA grants Orphan Drug Designation …

… PFAS) in seafood. The FDA is seeking scientific data and … a statement from the FDA. The FDA collects samples and tests … other seafood types, the FDA collected additional seafood samples … these interagency collaborations, the FDA is working to identify routes …

… US Food and Drug Administration (FDA) for its allogenic bone grafting … animal and human studies). The FDA-approved IND study is a … are thrilled to have received FDA approval for an IND trial …

… .S. Food and Drug Administration (FDA) under President-elect Donald Trump … also been critical of the FDA’s handling of COVID-19 … as the head of the FDA is not yet final, and …

The FDA has approved zanidatamab-hrii (Ziihera) … cancer as detected by an FDA-approved test, according to a … breakthrough therapy designation from the FDA for this indication, is an … Jazz Pharmaceuticals announces U.S. FDA approval of Ziihera® (zanidatamab-hrii …

… therapy designation from the FDA for this indication, is … accelerated approval pathway, the FDA may require verification and … Pharmaceuticals announces U.S. FDA approval of Ziihera® (zanidatamab … ;jazz-pharmaceuticals-announces-us-fda-approval-ziiherar Pant S, …

… of Medicine. “As the second FDA-ap­proved treatment to address the … proud to offer an additional FDA-approved treatment option for Alzheimer …

… the Food and Drug Administration (FDA) in Region VII  for … least 12 retail outlets sell FDA-banned cosmetics laden with mercury … . “We appeal to concerned FDA regulation officers in the region … the EcoWaste Coalition reported to FDA’s head office in Muntinlupa …

… , ovarian and pancreatic cancers. The FDA’s accelerated approval is based …

… Food and Drug Administration (FDA) accelerated approval of Ziihera® … Therapy Designation from the FDA for this indication, … Food and Drug Administration (FDA) granted accelerated approval for … the molecule. The FDA granted Breakthrough Therapy designation …

… .S. Food and Drug Administration (FDA) has approved UCB’s BIMZELX … this milestone BIMZELX is now FDA-approved for the treatment of … raising standards of care.” This FDA approval of bimekizumab-bkzx for …

… depend on it. Solution? Eliminate FDA’s clozapine REMS program and … Unnecessary For Safe Use, US FDA Adcomms Say. The Pink … -unnecessary-for-safe-use-us-fda-adcomms-say-KDK6ICJKNBHPTBGVFFL3C6ME7U/ … 2024. https://www.fda.gov/media/183655 …

The FDA has given clearance for a … of psychedelics and marijuana. The FDA had initially placed on partial … use. After discussions with the FDA, MAPS is able to proceed … cannabis during the trial. The FDA also no longer objects to …

UCB announced today that the FDA has approved Bimzelx (bimekizumab-bkzx) … news release. Bimzelx is also FDA approved to treat adults with …

… , was only greenlit by the FDA this week after years of … The New York Times. The FDA rejected the approval request for …

… announced today that it received FDA 510(k) clearance for its … pleased that the U.S. FDA has cleared our Respond critical … CEO Richard S. Walsh.” Achieving FDA 510(k) clearance for the … .S.-manufactured ventilator to receive FDA clearance in over 20 years …

… opposing COVID vaccine mandates. The FDA is the world's … ahead of any announcement. As FDA commissioner, Makary would report to … also held the role of FDA commissioner in the Obama administration …

… LLC, in conjunction with the FDA, has announced a voluntary recall …

… continues below advertisement The FDA found unsanitary conditions at a … "working with the FDA and are remedying the issues … safeguards to ensure compliance with FDA standards, and our water … The letter from the FDA was addressed to Colgate-Palmolive …

… more therapies becoming available, the FDA approval of EchoGo Amyloidosis is … until 2019, when Pfizer gained FDA approval for tafamidis meglumine and …

… the BE HEARD trials. The FDA has approved Bimzelx for the … inhibitor in this indication. The FDA has approved Bimzelx for the … this milestone Bimzelx is now FDA-approved for the treatment of …

… Recommendations? While the HHS Secretary, FDA Commissioner, and CDC Director cannot … ) during vaccine reviews, and the FDA Commissioner uses VRBPAC recommendations when … approvals and recommendations. For example: FDA evaluates the safety and effectiveness …

… or vaporizing) cannabis.” An FDA spokesperson told the New York … cannabis taxes to fund FDA-approved, nonprofit-sponsored clinical … pathways by challenging the FDA to think differently,” he … Benefit Corporation), that sought FDA approval earlier this year …

… regulatory initiatives from the FDA, including the final rule … thorough and constructive input that FDA seeks” on this issue … public hearing in September, FDA outlined​ its much-anticipated … ingredients within their borders, FDA Deputy Commissioner for Human …