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FDA investigating new outbreak of Listeria infections; continues work on other outbreaks
07 Dec 2023 06:24 GMT
Food Safety News
… information on the outbreak. The FDA has not reported where the … has begun, according to the FDA’s initial outbreak information. In … other news, the FDA continues to investigate an outbreak … on Nov. 1. The FDA has closed its investigation of …
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FDA Approves Iptacopan (Fabhalta) for Paroxysmal Nocturnal Hemoglobinuria
07 Dec 2023 06:14 GMT
HCPLive
… US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) … patients.” References: Novartis. Novartis receives FDA approval for Fabhalta® (iptacopan), offering … -releases/novartis-receives-fda-approval-fabhalta-iptacopan-offering-superior …
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CN Bio wins ‘Most Impactful Industry Collaboration of the Year’ at the OBN Awards 2023 for ongoing research with the FDA
07 Dec 2023 07:41 GMT
LabBulletin
… .S. Food and Drug Administration (FDA), aimed at advancing OOC adoption … , including the US Government’s FDA Modernization Act and similar acts … these challenges, in 2017, the FDA selected CN Bio as a … . By working closely with the FDA, our aim is to highlight …
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Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC
07 Dec 2023 06:00 GMT
GlobeNewswire, Inc.
… .S. Food and Drug Administration (FDA) has accepted the New Drug … nearly a decade. The target FDA PDUFA date under priority review …
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Ipsen confirme la décision de la FDA d'accorder un examen prioritaire pour le dépôt du dossier de demande d'autorisation d'elafibranor dans le traitement de la cholangite biliaire primitive, une maladie cholestatique rare du foie
07 Dec 2023 06:00 GMT
GlobeNewswire, Inc.
… ;hui que les autorités américaines (FDA : Food and Drug Administration) ont … date cible PDUFA de la FDA qui procède actuellement à un …
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Ipsen : FDA Grants Priority Review To Elafibranor NDA For Rare Cholestatic Liver Disease Treatment
07 Dec 2023 07:05 GMT
RTTNews
… nearly a decade. The target FDA PDUFA date under priority review …
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US FDA clears First Light Diagnostics' Rapid B. anthracis Toxin Test on the MultiPath Analyzer
07 Dec 2023 06:47 GMT
Pharmabiz.com
… US Food and Drug Administration (FDA) has cleared its SensiTox B …
- US FDA approves Novartis’ factor B inhibitor for rare blood disease 07 Dec 2023 05:53 GMT BioWorld
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US FDA approves Novartis' oral monotherapy, Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria
07 Dec 2023 04:23 GMT
Pharmabiz.com
… US Food and Drug Administration (FDA) approved Fabhalta (iptacopan) as … for blood transfusions.” The FDA approval is based on the … studies, Fabhalta has received FDA Breakthrough Therapy Designation in PNH … drug designations from the FDA and EMA in PNH and …
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FDA delays menthol ban following lobbying war
07 Dec 2023 01:49 GMT
Roll Call
… menthol cigarettes, according to FDA estimates, which accounts for … underage smokers, with the FDA estimating that nearly half … Vaping proponents say the FDA is stifling a potentially safer … strict approval parameters. The FDA would likely have faced legal …
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FDA: Ecuador plant that made lead-tainted fruit pouches is being inspected
06 Dec 2023 23:10 GMT
KIRO 7 - Washington State
… Read more trending news The FDA says they are conducting an … Austrofoods facility in Ecuador. The FDA is also collecting samples of … the ingredients. The FDA said that contaminated cinnamon is … , the AP reported. The FDA said that health officials in …
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FDA warns consumers about certain eye drops due to risk of eye infection
06 Dec 2023 23:09 GMT
KTVI - Missouri
… News in the Morning. “The FDA had concerns about whether the … a result of this.” The FDA said the products were marketed …
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NSite Medical Announces FDA Clearance for Groundbreaking AI-Based Scoliosis Scanning App
06 Dec 2023 22:54 GMT
BioSpace
… of scoliosis. This newly FDA-cleared AI-based Scoliosis Assessment … also noted, "Achieving FDA approval allows our company to … of this milestone. Achieving FDA clearance is a testament … #47;nsite-medical-announces-fda-clearance-for-groundbreaking-ai- …
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FDA renews conditional approval of medication for chemotherapy-induced diarrhea
06 Dec 2023 22:49 GMT
dvm360
… Health announced that the FDA has renewed the conditional … approval renewal from the FDA. This extension was granted … DVM, DACVIM (oncology). Reference FDA Approves Renewal of Canalevia-CA1 … news-release-details/fda-approves-renewal-canalevia-ca1-jaguar …
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Adaptimmune Completes Submission of Rolling Biologics License Application (BLA) to U.S. FDA for Afami-cel for the Treatment of Advanced Synovial Sarcoma
06 Dec 2023 22:37 GMT
BioSpace
… S. Food and Drug Administration (FDA) for afami-cel, an … to continued collaboration with the FDA as they review the … with synovial sarcoma." The FDA granted Orphan Drug Designation (ODD … synovial sarcoma. The last FDA approved therapy for treatment in …
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For first time ever, FDA approves at-home artificial insemination kit
06 Dec 2023 22:39 GMT
Savannah Now - Georgia
… -home insemination product approved by FDA Unusual birth:70-year-old … -the-counter option that was FDA-approved. With this method, fresh …
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Thousands of Americans Died Due to Internal FDA Strife Surrounding COVID Booster Rollout
06 Dec 2023 22:19 GMT
The Messenger - Florida
… thereafter,” the authors wrote. “However, FDA scientists and others questioned whether …
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Lead poisoning linked to applesauce pouches reported in more than 60 children, FDA says
06 Dec 2023 22:16 GMT
NBC News
… . 17 through Dec. 1. The FDA has homed in on the … allowed by the country, the FDA said. WanaBana did not immediately … lead poisoning or death. The FDA said that in the babies …
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FDA Mandates Changes to iPLEDGE Program for Isotretinoin
06 Dec 2023 22:10 GMT
Medscape
… 2023 joint meeting of the FDA's Drug Safety and …
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FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings
06 Dec 2023 22:01 GMT
Lexology
… Food and Drug Administration (FDA) has recently filed new … injunction proceeding indicates that FDA is conducting follow-up … the products receive FDA marketing authorization, FDA inspects the facilities … received warning letters, and FDA indicated in its press …
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FDA, DOJ Seek Permanent Injunction Against Vape Junkie Ejuice
06 Dec 2023 21:44 GMT
Convenience Store News & Petroleum
… e-cigarette products, the FDA said. This marks the … seventh time the FDA has initiated injunction proceedings … products to consumers, the FDA said. “FDA has been abundantly clear … obtain marketing authorization from the FDA before marketing such products. …
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FDA Seeks Penalties Against 25 Retailers Selling Illegal E-Cigarettes
06 Dec 2023 21:44 GMT
Convenience Store News & Petroleum
… are popular among youth, the FDA said. Findings from the 2023 … .6%, the survey found. The FDA had warned these retailers to … violation from each retailer, the FDA said. Retailers must pay the … complaint, the agency said. The FDA has filed 67 CMPs against …
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FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
06 Dec 2023 21:13 GMT
National Law Review
… requirement established by the FDA Amendments Act of 2007 … Stakeholders have concerns regarding FDA’s enforcement of format regulations … sought clarification on the FDA’s formatting requirements for … for consumer protection. The FDA aims to enable consumers …
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MOSIE BABY BECOMES THE FIRST COMPANY TO RECEIVE FDA CLEARANCE FOR AT-HOME INTRAVAGINAL INSEMINATION
06 Dec 2023 20:54 GMT
BioSpace
… care company, has secured FDA Class II clearance for its … technology adheres to the highest FDA recognized test standards and is … syringe designed, patented and now FDA-cleared specifically for at-home … the-first-company-to-receive-fda-clearance-for-at-home- …
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OSSIO’s Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance
06 Dec 2023 20:27 GMT
Business Wire
… . Food and Drug Administration (FDA): This press release features multimedia … 47; OSSIOfiber Compression Screw The FDA has cleared the company’s … of the technology’s FDA clearance for use in … fixing fractured bones.” The FDA’s approved instructions for the …