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The FDA's New Cybersecurity Guidance for Medical Devices Reminds Us That Safety & Security Go Hand in Hand
26 May 2022 17:40 GMT
Dark Reading
… Administration premarket approval — the FDA process of review to evaluate … cybersecurity draft guidance, the FDA has decided to issue a … Until July 7, the FDA is inviting medical device manufacturers … for medical devices. While FDA guidance is nonbinding, the …
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FDA commissioner Robert Califf expects baby formula shortage to end within two months
26 May 2022 18:47 GMT
CNBC
… production restarts. The FDA has eased import restrictions … products in February after FDA inspectors found Cronobacter … ; Califf told lawmakers. FDA inspectors found shocking conditions … inspection. Though the FDA received the whistleblower complaint …
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High Hopes For Alcohol Use Disorder Treatment: Clearmind's Successful Pre-IND Meeting With The FDA
26 May 2022 17:57 GMT
Benzinga
… compound CMND-100. “The FDA's interest in CMND … is aiming to initiate FDA-regulated clinical trials with … IND meeting package to the FDA in April, which included … (IND) application. Responses from FDA representatives were constructive and supportive …
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OmniGuide Holdings Receives FDA Clearance for RevoLix™ HTL Hybrid Thulium Laser for the treatment of BPH and Stones
26 May 2022 16:43 GMT
Business Wire
… ;20220525006058/en/ “The FDA's clearance reflects our … stone and urine medium.” The FDA cleared Revolix™ HTL, LISA Laser …
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Apyx Medical Stock Gains Following FDA Clearance of Renuvion Dermal Handpiece for Wrinkle Reduction
26 May 2022 17:02 GMT
Benzinga
… .S. Food and Drug Administration (FDA) announced 510(k) clearance (pre … are very pleased to receive FDA 510(k) clearance with a …
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FDA approves Servier’s Tibsovo-azacitidine combo therapy for AML
26 May 2022 17:30 GMT
Pharmaceutical Technology
… US Food and Drug Administration (FDA) has granted approval for Servier …
- Servier's Tibsovo snags FDA combo nod in first-line AML, expanding its use in tough-to-treat cancer 26 May 2022 17:41 GMT Fierce Pharma
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FDA approves ivosidenib plus azacitidine for certain patients with acute myeloid leukemia
26 May 2022 15:54 GMT
Healio News
… .com. Back to Healio The FDA approved ivosidenib tablets in combination … metastatic IDH1-mutated cholangiocarcinoma. The FDA based the approval of the …
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Lawmakers Seek Answers From FDA, Abbott On Nationwide Baby Formula Shortage
26 May 2022 15:15 GMT
Benzinga
FDA officials appeared before a congressional … are also questions surrounding the FDA's investigation and response … former Abbott employee whistleblower. Related: FDA Allows Import Of 2M Baby …
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FDA Black Box Label Warns of Suicide Risks
26 May 2022 15:15 GMT
EIN Presswire
… and Drug Administration's (FDA) black box warning of increased …
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Lawmakers Grill US FDA on Response to Abbott Baby Formula Safety
26 May 2022 14:52 GMT
Medscape
… to severe nationwide shortages. FDA leaders appeared before a … surrounding the timeline of FDA's investigation and … mail routing issues, FDA officials said. "FDA's … more optimal," acknowledged FDA Commissioner Robert Califf. …
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Avadel stock falls 26% as FDA cites patent issue in sleep disorder drug FT218 filing; expects tentative approval in 2023
26 May 2022 14:43 GMT
Seeking Alpha
… amp; Drug Administration (FDA). In October 2021, the FDA had delayed to … was deemed inappropriate by the FDA. FDA has asked the company to … The company noted that the FDA confirmed, based on the … a court determines that FDA erred in requesting a certification …
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Perrigo Shares Rise 2% After FDA Approves Omeprazole Mini Capsules
26 May 2022 14:16 GMT
MarketWatch
By Chris Wack Perrigo Co. Plc shares were up 2%, to $39.94, after the company said it has received final approval from the U.S. Food and Drug Administration for omeprazole magnesium delayed-release mini capsules, 20 mg over-the-counter. The company expects …
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Pharma Stock Shoots Up As FDA Accepts NDA For Neuromuscular Disorder Drug Under Priority Review
26 May 2022 13:43 GMT
Benzinga
… Nov. 30, 2022. Additionally, the FDA indicated that the agency is … Officer, said, "With the FDA's acceptance of our … launch in early 2023. The FDA grants Priority Review that shortens …
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Pfizer's Combo Therapy For Fatty Liver Disease Gets FDA Fast Track Status
26 May 2022 13:44 GMT
Benzinga
… improvement in liver fibrosis. The FDA's decision is supported … Fast Track designation from the FDA reinforces Pfizer's belief …
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Fact Check: Did FDA Shut Down Abbott's Baby Formula Factory?
26 May 2022 13:42 GMT
Newsweek
… Abbott products sparked the recent FDA investigation. An inspection, … Nutrition CEO acknowledged an FDA investigation "did discover … issues raised by the FDA." Subsequently, Abbott … no additional comment. The FDA provided previously published press …
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FDA reveals dire 'unsanitary' conditions at baby formula plant linked to shortages, including broken equipment
26 May 2022 13:17 GMT
Business Insider India
… " conditions, the FDA said. FDA commissioner Robert Califf said … Food and Drug Administration. FDA commissioner Robert Califf said … bacteria, cronobacter sakazakii. The FDA could not link the … internal issues within the FDA that delayed an investigation …
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Apyx Medical Gets 510(k) Clearance From FDA for Renuvion Dermal Handpiece
26 May 2022 13:18 GMT
MarketWatch
By Chris Wack Apyx Medical Corp. said it has received 510(k) clearance from the U.S. Food and Drug Administration for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for …
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The Daily Biotech Pulse: Setback For NRx Pharma's COVID Study, Fast Track Tag For Pfizer's NASH Combo Therapy, Reata's Ataxia Drug In FDA Review
26 May 2022 12:57 GMT
Benzinga
… and commercialize cilta-cel. The FDA has accepted Reata Pharmaceuticals Inc … in the U.S. The FDA has granted Fast Track designation …
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Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
26 May 2022 12:51 GMT
Business Wire
… .S. Food and Drug Administration (“FDA”) for the use of the … are very pleased to receive FDA 510(k) clearance with a … ; the impact of the recent FDA Safety Communication on our business …
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Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion(R) Cosmetic Technology in Dermal Resurfacing Procedures
26 May 2022 12:47 GMT
Tradingcharts
… . Food and Drug Administration ("FDA") for the use of … are very pleased to receive FDA 510(k) clearance with a … ; the impact of the recent FDA Safety Communication on our business …
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FDA Grants Fast Track Designation To Pfizer's Ervogastat Combination For Liver Disease Treatment
26 May 2022 12:29 GMT
RTTNews
… Fast Track designation from the FDA reinforces Pfizer's belief …
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Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics
26 May 2022 12:15 GMT
Business Wire
… US Food and Drug Administration (FDA) for a molecular SARS-CoV … patent-pending and U.S. FDA Class I exempt RHINOstic Automated … devices with the U.S. FDA and may be used for …
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Two Day Virtual Training Course: Analytical Instrument Qualification and Validation - Understanding Use of Excel and FDA Audit Preparation (July 25-26, 2022) - ResearchAndMarkets.com
26 May 2022 11:49 GMT
Business Wire
… Understanding Use of Excel and FDA Audit Preparation" training … in compliance with the FDA regulations for analytical equipment … instruction on preparing for FDA audits and becoming part … #47;or respond to FDA inspectional observations and warning …
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Hyundai to submit fast track processing request to FDA for monkeypox drug
26 May 2022 11:29 GMT
Pharmaceutical Technology
… US Food and Drug Administration (FDA). Niclosamide is the active ingredient … the Animal Rule from the FDA. The Animal Rule is a … of CP-COV03 to the FDA quickly. Scientists at Kansas State … treatment for monkeypox with the FDA’s fast-track designation, we …