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FDA Approves Belimumab Autoinjector for Pediatric Lupus
Medscape· 18 hours agoThis enables at-home administration of the medication, which was previously available only via intravenous infusion.
FDA Grants Withdrawal of Infigratinib for Cholangiocarcinoma
Medscape· 18 hours agoThe US Food and Drug Administration (FDA) has announced the withdrawal of its 2021 accelerated approval of infigratinib (Truseltiq) for patients with a certain type of previously ...
Breaking: FDA authorizes second patient for Elon Musk's Neuralink brain chip trial | Invezz
Invezz· 1 day agoThe United States Food and Drug Administration (FDA) has authorized a second patient for Neuralink’s...
Critics Say FDA's Use of Surrogate Markers Falling Short
Medscape· 5 days agoAs the FDA's use of surrogate endpoints in the drug approval process is increasing, researchers are...
FDA issues import alerts against 2 more plastic syringe manufacturers
MedTech Dive via Yahoo Finance· 5 days agoIn March, the FDA strengthened its recommendations, asking U.S. suppliers, consumers and healthcare...
FDA issues 510(k) clearance for Implicity’s SignalHF1 algorithm
Medical Device Network via Yahoo Finance· 2 days agoLast year, Implicity launched a new algorithm for reducing alert fatigue in the remote monitoring of...
FDA Broadens Breyanzi's Follicular Lymphoma Indication
Medscape· 6 days agoThe overall response rate to the CAR T therapy was 95.7% in phase 2 testing.
Recall alert: Reser’s Fine Foods announces voluntary recall of of Aldi macaroni salad
WSOC-TV Charlotte· 1 day agoThe salad was distributed to Aldi location in 15 states, including Florida, Georgia, Massachusetts,...
FDA said it never inspected dental lab that made controversial AGGA device
San Jose Mercury News· 4 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
FDA Roundup: May 17, 2024
The Pilot News· 4 days agoOn Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression ...
