FDA Newsfeed

… that has faced significant FDA scrutiny, including import alerts … Food and Drug Administration (FDA) has escalated a nationwide … to these recalls includes significant FDA scrutiny of Intas… adulterated." Notably, the FDA's correspondence to Intas …

… The Food and Drugs Authority (FDA) has granted authorisation to … Frimpong-Manso Opuni, the FDA confirmed that the company had … The move, taken under FDA supervision, was described by … expressed appreciation to the FDA for its collaborative approach …

… .S. Food and Drug Administration (FDA) approval of a supplemental new … prescription drugs to the FDA. Visit  www.fda.gov/medwatch or … call 1-800-FDA-1088. Globally, prescribing information varies …

… to collaborate with the FDA in developing novel … communication channels with the FDA, including frequent advice … sustained collaboration with the FDA throughout the endpoint … insights through public workshops, FDA presentations, guidance documents, and …

… operational. Second, the FDA will hold pre-submission … biologic approval applications. The FDA has issued CMC-related rejections … days after contacting the FDA. Reassessing post-approval change … facilities, attendees told the FDA. Next Steps Overall, feedback …

… in January, the company received FDA registration for its QuantumPACK Easy … . “We are steadily expanding our FDA registrations and laying the foundation …

US FDA Recalls Frozen Spinach Over Listeria … US Food and Drug Administration (FDA) has issued a recall for … illnesses have been reported,” the FDA said in its statement. Authorities … the 10-ounce bags. The FDA said production of the frozen …

FDA has approved another blood test … Alzheimer’s biomarkers that received FDA approval this year. The first …

… Food & Drug Administration (FDA) has cleared the first blood … 9% negative predictive value. With FDA clearance, the Elecsys pTau181 … and CSF testing. Beyond FDA clearance in the United States … -listing/2025/fda-cleared-ptau181-alzheimers-blood-test …

… y Medicamentos de EE.UU. (FDA, por sus siglas en inglés … recibe la aprobación de la FDA para la enfermedad de Alzheimer … recibió la aprobación de la FDA. “Este es un claro ejemplo …

… based biomarker test to receive FDA clearance for Alzheimer’s disease … when the Lumipulse test received FDA clearance.“This is a … based biomarker test to receive FDA clearance for Alzheimer’s disease … when the Lumipulse test received FDA clearance. “This is a …

The U.S. FDA has approved Elecsys pTau181, a …

… announced that the U.S. FDA has extended its review date …

… . STAT previously reported that an FDA inspection of the plant over … ’s in contact with the FDA and its manufacturing customers about …

… type 2 diabetes. The FDA assigned a Prescription Drug User … switched to Afrezza. The FDA first approved Afrezza for adults … References MannKind announces U.S. FDA accepts for review its supplemental … #47;mannkind-announces-us-fda-accepts-review-its-supplemental

… initially approved by the FDA in 2022 for adults with … (TPN). According to the FDA, the condition has, in … most commonly corticosteroids.3 The FDA advises that patients exhibiting symptoms … benefit in treated patients. “FDA has determined that the overall …

… Food and Drug Administration (FDA) Approves Updated Indication Statement … Food-and-Drug-Administration-FDA-Approves-Updated-Indication- … -Bowel-Disease 2. FDA Approves Upadacitinib for Moderately … -ulcerative-colitis 3. FDA Approves Upadacitinib for Adults …

The FDA has granted breakthrough therapy designation … therapy designation by U.S. FDA for 1L HPV-Negative R …

Paris: The FDA has approved UZEDY, the first … depressive symptoms, and today’s FDA approval of UZEDY provides a … Congress events and programs. “The FDA’s decision to expand the … .” The data reviewed by the FDA to support UZEDY’s approval …

… Regeneron, which has two FDA applications pending for eye disease … biotech also said the FDA had slotted the Bloomington … Three weeks ago, the FDA rejected Scholar Rock’s application … ago, Regeneron revealed the FDA had extended the target decision …

… marketing adverse event data, the FDA said. Those who have developed … 45% over standard therapies. The FDA recommends that patients with IEC … . Four months ago, the FDA removed its Risk Evaluation and … CAR-T therapies. The FDA approved Carvykti in 2022 and …

… -based biomarker test to receive FDA clearance for Alzheimer’s disease … when the Lumipulse test received FDA clearance. “This is a clear …

… :MNKD) announced today that the FDA accepted a supplemental biologics license …