FDA Newsfeed

… user fees, or costs the FDA charges to pharmaceutical companies with … : 3,500 jobs at the FDA, which inspects and sets safety …

… , has now become the first FDA-approved treatment for Immunoglobulin G4 …

… reported Wednesday, citing multiple FDA officials. The HHS cuts … downsizing effort will spare FDA inspection staff specifically, … staff positions in the FDA, rather than inspectors themselves … the spokesperson explained. “FDA inspectors were not impacted …

… very low," the FDA wrote. The FDA went on to warn … contaminants like benzene. "FDA has continued to raise concern … to consumer confusion," the FDA said. Valisure heated acne … a human. And though the FDA similarly rejected those findings, …

… case concerned whether the FDA lawfully denied respondents authorization … “new tobacco product” without FDA authorization. The TCA requires … particular concern about the FDA’s failure to review … sufficiently consistent with the FDA’s predecisional guidance—as …

… to adjust to a diminished FDA — which oversees the industry — … no longer employed,” wrote ex-FDA Commissioner Robert M. Califf … arbitrary dismissal of HHS and FDA employees. Equally disturbing is the … Council, said that the FDA layoffs will have a tangible …

… health care costs,” Harve said. FDA layoffs hit device office Tariffs … thousands of employees across the FDA, CDC, NIH and more. … still in place at the FDA. Former FDA Commissioner Robert Califf, MD … according to a search of FDA databases on approvals between …

… designation follows the December 2022 FDA fast track designation that was … References IDEAYA Biosciences receives US FDA breakthrough therapy designation for darovasertib … 31-IDEAYA-Biosciences-Receives-US-FDA-Breakthrough-Therapy-Designation-for-Darovasertib …

… US Food and Drug Administration (FDA) has issued a Complete Response … reproxalap were identified, the FDA stated in the letter that … eye chamber trials. Again, the FDA found no manufacturing or safety … with reproxalap. However, the FDA stated in the 2025 CRL …

… payment tied to the timely FDA approval of atrasentan without a … milestone has been met. The FDA has granted an accelerated approval … to be used under an FDA-mandated safety-related program … submitted an application to the FDA to potentially reduce the REMS …

… Food and Drug Administration (FDA) has issued a Complete Response … April 3, 2025, the FDA determined the trials had … eyes” as defined by the FDA. Aldeyra announced the resubmission … trials. Pending discussions with the FDA, the company intends to …

… S. Food And Drug Administration (FDA) granted Emergency Use Authorization to … . Food and Drug Administration (FDA)'s Prescription Drug User … decision from the U.S. FDA. Our application included robust … , according to sources. The FDA set an April 1 deadline …

… to Healio According to the FDA, reproxalap did not demonstrate … soon for updates. The FDA issued a complete response letter … from Aldeyra Therapeutics. The FDA did not approve reproxalap for … issues were reported. The FDA also said methodological issues with …

… trials and discussions with the FDA. Shares of Aldeyra Therapeutics, … Food and Drug Administration (FDA) said the company’s … of dry eye. The FDA, however, identified no manufacturing … trials and discussions with the FDA. On Stocktwits, retail investor …

… on March 4. Covering 21 FDA-approved products, the inspection … followed the FDA's six-system … inspection model. The FDA inspectors concluded the review one … and Taixing sites passed their FDA inspections with no observation. …

… the Food and Drug Administration (FDA), she worked on some … key public health agencies: The FDA, which ensures the safety … the American public. From spearheading FDA’s communication strategy in the … and her colleagues at the FDA worked tirelessly behind the …

… health agencies, including the FDA, where the departures included … has deteriorated further. The FDA sounds like it may be … have suggested that the FDA may ultimately come out … potentially disruptive changes at the FDA". Investment bank Cantor …

… Food and Drug Administration (FDA) has granted Breakthrough Device … results for patients.” The FDA established the Breakthrough Devices Program … later became the first FDA-authorized AI application in … of being the first FDA-cleared AI application in …

… twice as likely to earn FDA approval compared with other … from theoretical to practical, with FDA-approved therapies jumping from zero … license application submitted to the FDA has failed to gain … CRISPR-based therapy to receive FDA approval. In the earlier …

… the drug first entering the FDA database on July 18, … to the authors.3 The FDA initially approved liraglutide in … #47;news/100 2. FDA Drug Shortages: liraglutide injection. April … 2025. https://dps.fda.gov/drugshortages/activeingredient …

The FDA has granted accelerated … it is considered for traditional FDA approval.1 "The … 1. Novartis. Novartis receives FDA accelerated approval for Vanrafia (atrasentan … releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first …

… Food and Drug Administration (FDA) on Wednesday granted accelerated approval … to placebo. Also Read: FDA Reviews Kidney Disease Drug … intended to support traditional FDA approval. In the ongoing … year. Fabhalta was granted FDA approval in C3 glomerulopathy …

… conjunctivitis. In the letter, the FDA stated that the NDA … ; should be conducted. Further, the FDA pointed out concerns with the … to the initial NDA, the FDA stated that at least one …

… claimed accelerated approval from the FDA for Vanrafia, one of a … Tarpeyo (budesonide) became the first FDA-approved therapy for IgAN, and … defects. Otsuka recently filed for FDA approval of its anti-APRIL …

… .S. Food and Drug Administration (FDA) has reported that, on April … dispose of it under the FDA’s instructions.