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FDA grants brensocatib priority review for bronchiectasis
10 Feb 2025 16:26 GMT
Healio News
… deadline is Aug. 12. The FDA has granted priority review to … for this patient population. The FDA has granted priority review to … of Insmed, told Healio. “The FDA’s priority review of brensocatib … as soon as possible.” The FDA based this decision, in part …
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Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for NXC-201, sterically-optimized CAR-T for relapsed/refractory AL Amyloidosis
10 Feb 2025 14:35 GMT
GlobeNewswire, Inc.
… frequent interactions with FDA and routes to FDA Accelerated Approval and … medical needs. “Receipt of FDA RMAT designation underscores the … , where no drugs are FDA approved today,” said Ilya … frequent interactions with the FDA to discuss potential surrogate …
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Experts Comment on the GI/GU Cancer FDA Approvals From 2024
10 Feb 2025 13:27 GMT
OncLive
… positive, as determined by an FDA-approved test Month: October … alterations, as determined by an FDA-approved test, whose disease … of systemic therapy. The FDA noted that this approval amends … New drug therapy approvals 2024. FDA. Accessed February 4, 2025. …
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FDA posts early alert about BD device linked to 30 injuries, 4 deaths
10 Feb 2025 15:58 GMT
MedTech Dive
… Rotarex device to break, the FDA said, and result in … September, BD wrote to the FDA to update the instructions for … of fractures and breaks. The FDA is also still reviewing information … available. In the past, the FDA often shared information about safety …
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Ibex Medical Analytics Receives First FDA 510(k) Clearance
10 Feb 2025 13:28 GMT
Business Wire
… laboratories as part of the FDA clearance, the system demonstrated … of care.1 “The FDA clearance marks a significant milestone … Ibex Prostate Detect is FDA cleared and other solutions … validation studies submitted to the FDA (unpublished). Pantanowitz et al. …
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FDA recalls 2 million donuts nationwide for listeria: What to know
10 Feb 2025 16:09 GMT
The Oklahoman
The Food and Drug Administration (FDA) has issued a recall for … . and Canada, according to the FDA report. The reason for the … ," according to the FDA’s website. The FDA did not specify … can be found on the FDA's website. Listeria poisoning …
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Novel Molecular Imaging Agent for Detection of Bowel Inflammation in Crohn Disease Receives FDA FTD
10 Feb 2025 16:10 GMT
Pharmacy Times
… The new FTD by the FDA will allow for a more … eventual approval.1 "The FDA fast track process is designed … Bracco Imaging. Bracco Imaging receives FDA fast track designation for BR55 … releases/bracco-imaging-receives-fda-fast-track-designation-for-br55 …
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Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer and Plans for FDA Alignment on Next-Stage Development
10 Feb 2025 13:00 GMT
GlobeNewswire, Inc.
… and will engage with the FDA this year to align … in resistant tumors. Next Steps: FDA Alignment and Preclinical Advancements With … preparing for discussions with the FDA to determine the regulatory … use in patients by the FDA. Such approval, if granted, …
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The FDA Issued a Class II Recall on More Than 2 Million Baked Goods — Including Dunkin' Products
10 Feb 2025 14:15 GMT
Food & Wine
… , the Food and Drug Administration (FDA) released a recall for 60 … Class II recall, which the FDA defines as "a situation … , and Just Baked Eclairs. The FDA notes in its release that … balance, [and] seizures." The FDA did not issue guidance on …
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LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
10 Feb 2025 14:25 GMT
Business Wire
… S. Food and Drug Administration (FDA) has accepted for review the … to approved PCSK9 inhibitors. The FDA has set a Prescription Drug … of December 12, 2025. The FDA is not currently planning to … plasma half-life. Following the FDA BLA filing, LIB is anticipating …
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S4 Medical Corp Launches Atrial Fibrillation Esophageal Protection Device Following FDA Clearance
10 Feb 2025 15:54 GMT
EIN Presswire
… has the first and only FDA approved device to prevent ablation … fistula. The company received an FDA De Novo grant in September … , which concluded in attainment of FDA 510(k) clearance in November …
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Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
10 Feb 2025 13:30 GMT
GlobeNewswire, Inc.
… 10, 2025 Biodexa Receives US FDA Fast Track Designation for eRapa … US Food and Drug Administration (“FDA”) has granted Fast Track designation … Europe2. Biodexa has received US FDA Orphan Drug designation for eRapa …
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AbbVie scores FDA nod for Pfizer-partnered antibiotic Emblaveo
10 Feb 2025 16:06 GMT
Fierce Pharma
… the U.S., winning an FDA nod for Emblaveo for the … rest of the world. The FDA approval covers Emblaveo to be … fast track designations from the FDA in 2019. Grants from the …
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FDA approves AbbVie’s Emblaveo for intra-abdominal infections
10 Feb 2025 13:02 GMT
Pharmaceutical Technology
… US Food and Drug Administration (FDA) approval for Emblaveo (aztreonam and … networks. In October 2024, the FDA approved AbbVie’s Vyalev for …
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ACR-368 OncoSignature Assay Receives FDA Breakthrough Device Designation for Endometrial Cancer
10 Feb 2025 14:32 GMT
Pharmacy Times
The FDA granted a breakthrough device designation … “We are pleased that the FDA has designated our ACR-368 …
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FDA Grants Fast Track Designation to Rezpegaldesleukin for Atopic Dermatitis
10 Feb 2025 15:53 GMT
Drug Topics
The FDA granted fast track designation to …
- FDA recalling baked goods over safety concerns 10 Feb 2025 15:18 GMT FOX 10 Phoenix - Arizona
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INmune Bio Announces Plan to Submit FDA Biologics License Application (BLA) Seeking Approval of CORDStrom for Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
10 Feb 2025 12:00 GMT
GlobeNewswire, Inc.
… over current MSC products. FDA grants CORDStrom a Rare Pediatric … occur marketing authorization from the FDA, EMA, or MHRA, and … or sold. Additionally, the FDA granted CORDStrom an orphan drug … to frequent meetings with the FDA for efficient drug development, …
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The FDA just approved a new painkiller. Is it too good to be true?
10 Feb 2025 10:58 GMT
Salon
… Incorporated’s suzetrigine, a newly FDA-approved painkiller that also goes … profile, which is necessary for FDA approval,” Friedmann said “Noninferiority would …
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Hyderabad-based Natco Pharma gets FDA approval for marketing Bosentan Tablets in the United States
10 Feb 2025 10:54 GMT
Telengana Today
… Limited got yet another US FDA approval for manufacture of Bosentan … and Drug Administration (U.S.FDA) for Natco’s Abbreviated New …
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AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray
10 Feb 2025 10:43 GMT
WFMZ - Pennsylvania
… .S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Celiac … Disease (CD) microarray to the FDA for 510(k) clearance. Considering … -releases/alivedx-announces-us-fda-510k-submission-for-mosaiq-aiplex …
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Lupin and Natco receive US FDA approval for generic Tracleer tablets for oral suspension
10 Feb 2025 10:17 GMT
Pharmabiz.com
… States Food and Drug Administration (FDA) for Natco’s Abbreviated New …
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Hikal shares drop over 6% after US FDA issues six observations for Jigani facility
10 Feb 2025 09:53 GMT
Business Upturn
… Food and Drug Administration (US FDA) for its Jigani facility in … to ensure compliance with US FDA guidelines. While the company has …
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AbbVie receives US FDA approval for Emblaveo to treat adults with complicated intra-abdominal infections with limited or no treatment options
10 Feb 2025 09:46 GMT
Pharmabiz.com
… US Food and Drug Administration (FDA) has approved Emblaveo (aztreonam … -threatening or fatal. The FDA has prioritized the research and … options. In 2019, the FDA granted Qualified Infectious Disease Product … review and eligibility for the FDA's Fast Track …
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FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025
10 Feb 2025 08:27 GMT
Citizen Tribune - Tennessee
… Food and Drug Administration (FDA) has accepted the Company… communication to Insmed, the FDA granted Priority Review to … placebo, respectively. The FDA grants Priority Review to applications … a serious condition. The FDA had previously granted brensocatib …