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US FDA Committee to review AstraZeneca's Imfinzi to treat resectable NSCLC based on AEGEAN phase III trial results
27 Jul 2024 05:13 GMT
Pharmabiz.com
… and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee ( … regimen for patients. The FDA accepted the supplemental Biologics License … working closely with the FDA to bring this novel … . The ODAC provides the FDA with independent, expert advice …
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FDA Issues Public Health Alert About Lead Contamin
27 Jul 2024 04:38 GMT
NTD
… Markets and confirmed by the FDA, the FDA has determined that the … ,” the agency said. The FDA recommended that consumers throw away … . Lead Warnings The latest FDA ground cinnamon alert joins an … . In January 2023, the FDA issued a statement announcing its …
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20 Years after Landmark FDA Approval, SynCardia Remains World's Only Commercially Approved Total Artificial Heart
27 Jul 2024 00:24 GMT
L A Downtown News - California
… Food & Drug Administration (FDA). Since then, a number of … SynCardia Total Artificial Heart received FDA approval on Oct. 15, … and only commercially available FDA and Health Canada approved … ;20-years-after-landmark-fda-approval-syncardia-remains-worlds- …
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Sen. Klobuchar, three other elected officials, announce new FDA Rare Disease Innovation Hub
26 Jul 2024 23:15 GMT
KTTC - Minnesota
… , D.C. (KTTC) – A new FDA Rare Disease Innovation Hub has … Disease Congressional Caucus, demanding the FDA to improve their process of … , expressed her pleasure with the FDA taking heed to the concerns …
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FDA warns of adverse events due to overdosing of compounded semaglutide
26 Jul 2024 23:12 GMT
Healio News
… In the release, the FDA noted compounders offer injectable semaglutide … events reported to the FDA tied to compounded semaglutide … 2 diabetes and obesity. FDA-approved injectable semaglutide products … for adverse events. The FDA said people using compounded …
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FDA approves oral JAK inhibitor Leqselvi for severe alopecia areata in adults
26 Jul 2024 23:12 GMT
Healio News
… alopecia areata in adults. The FDA has approved Leqselvi 8 mg … this indication were limited. The FDA has approved Leqselvi 8 mg … alopecia areata, marking the third FDA approval for alopecia areata in …
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US FDA flags dosing risks from compounded versions of Novo's weight-loss drug
26 Jul 2024 23:11 GMT
Investing
… healthcare providers miscalculating doses. The FDA flagged the higher risk to … versions, sometimes even counterfeits. The FDA has also expressed serious concerns …
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Produce in FDA recall was shipped to Kentucky
26 Jul 2024 23:07 GMT
WKYT - Kentucky
… , check your produce! The FDA says a potential listeria contamination … once-smaller recall. The FDA is recalling bulk produce distributed … A few weeks ago, the FDA recalled only cucumbers from Wiers … ,” said Dr. Hood. The FDA has confirmed that there have …
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Sun Pharma’s JAK inhibitor for severe alopecia gets US FDA nod
26 Jul 2024 23:04 GMT
BioWorld
The U.S. FDA has approved Sun Pharmaceutical Industries … .S. This is the third FDA-approved treatment for severe alopecia … molecule Asia-Pacific U.S. FDA
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FDA Roundup: July 26, 2024
26 Jul 2024 23:00 GMT
U.S. Food and Drug Administration
… the agency: Today, the FDA approved Palforzia [Peanut (Arachis … Campylobacter. On Thursday, the FDA published the Digital Health … . On Wednesday, the FDA announced the virtual Medical Device … submit questions to MedicalDeviceSterilization@fda.hhs.gov by 4 …
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FDA issues advisory for Freeport oysters over potential contamination
26 Jul 2024 23:10 GMT
WABI - Maine
FREEPORT, Maine (WMTW) - Restaurants and food distributors around the country have been told to dispose of oysters harvested between June 19 and July 16 from sites in Recompense Cove, Freeport. These oysters have been linked to a Campylobacter illness …
- Actinium Pharmaceuticals obtains FDA clearance for trial of Iomab-ACT in sickle cell disease 26 Jul 2024 23:10 GMT BioWorld
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CDRH Director Jeff Shuren to Leave FDA
26 Jul 2024 22:54 GMT
GovCIO Media & Research
… Food and Drug Administration (FDA), is retiring from a … will officially leave the FDA later this year following … center director emeritus, according to FDA Commissioner Robert Califf. “Today, … During his tenure at the FDA, Shuren created and implemented …
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FDA Warns Consumers Not to Use Kratom Product Linked to a Death
26 Jul 2024 22:49 GMT
Financial Post
… to the statement on the FDA’s website. The agency has … its more concentrated forms. The FDA continues to warn consumers not … Townsend & Stockton, said the FDA’s announcement “was a surprise …
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FDA Grants Regenerative Medicine Advanced Therapy Designation to Kyverna's KYV-101 for Refractory Stiff-Person Syndrome
26 Jul 2024 22:39 GMT
NeurologyLive
… to a recent announcement, the FDA has granted regenerative Medicine Advanced … and the support of the FDA oversight," Amanda Piquet, MD … KYV-101 Receives U.S. FDA RMAT Designation for KYV-101 … ;kyvernas-kyv-101-receives-us-fda-rmat-designation-for-kyv-101 …
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People are overdosing on off-brand weight-loss drugs, FDA warns
26 Jul 2024 21:35 GMT
Ars Technica - New York
… of intended semaglutide, the FDA reports. Though the … provide personalized formulations of FDA-approved drugs, for instance … to an incorrect dosage. FDA-approved semaglutide drugs, meanwhile, … than intended. "FDA recognizes the substantial consumer …
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FDA recall pinpoints specific brand, varieties of deli meats
26 Jul 2024 21:13 GMT
Brooklyn Eagle - New York
… /07/26/fda-recall-pinpoints-specific-brand-varieties …
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FDA Approves Deuruxolitinib for Alopecia Areata
26 Jul 2024 20:51 GMT
The American Journal of Managed Care
The FDA has approved deuruxolitinib as a … . We are excited that the FDA is elevating another potential treatment … 1. Sun Pharma announces US FDA filing acceptance of new drug … /Sun-Pharma-Announces-US-FDA-Filing-Acceptance-for-Deuruxolitnib.pdf …
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Almac Charnwood Commercial Manufacturing Plant Successfully Passes FDA Inspection
26 Jul 2024 20:42 GMT
Pharmaceutical Commerce
… has successfully completed its first FDA inspection of its commercial manufacturing … . Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities … almac-pharma-services-announces-successful-fda-inspection-at-charnwood-uk-facilities …
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FDA Roundup: July 26, 2024
26 Jul 2024 20:34 GMT
U.S. Food and Drug Administration
… the agency: Today, the FDA approved Palforzia [Peanut (Arachis … Campylobacter. On Thursday, the FDA published the Digital Health … . On Wednesday, the FDA announced the virtual Medical Device … submit questions to MedicalDeviceSterilization@fda.hhs.gov by 4 …
- Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns 26 Jul 2024 20:50 GMT Endpoints News
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FDA committee proposes overhaul of perioperative lung cancer trials
26 Jul 2024 20:28 GMT
Pharmaceutical Technology
… and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee … form By GlobalData The FDA also highlighted its … In September 2023, the FDA accepted the supplemental Biologics … pembrolizumab) plus chemotherapy gained FDA approval as a perioperative …
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FDA recalls vegetables due to listeria
26 Jul 2024 20:29 GMT
AS
… listeria contamination. According to the FDA recall announcement, Wiers Farm expanded … for a full refund. The FDA clarifies “there have been no …
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FDA issues warning over Freeport oysters
26 Jul 2024 18:57 GMT
WMTW 8 - Maine
FDA issues advisory for Freeport oysters …
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JNJ-2056, Targeting Tau Protein, Receives FDA Fast Track Designation for Alzheimer Disease
26 Jul 2024 18:22 GMT
Pharmacy Times
The FDA has granted a fast track … .030 (now “JNJ-2056”) granted FDA Fast Track Designation for Alzheimer … -35030-now-jnj-2056-granted-fda-fast-track#:~:text=ACI%2D35.030%20is%20designed%20to …