Search News
-
Published on Jun 24, 2025Source: WKZO - Michigan - Pending
-
Published on Jun 24, 2025
Q&A: FDA expands approval of wearable device to treat nasal congestion in adolescents
Add topic to email alerts Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The SONU Band was initially approved for …
Source: Healio News - Neutral -
Published on Jun 24, 2025
Britt attacks use of synthetic food dyes, praises FDA phase out plan
Senator Katie Britt, R-Alabama, took to social media this weekend to criticize the use of artificial food dyes. In a Saturday post on X, Britt shared an April story from WHNT News 19 about a Huntsville bakery that claims to have ditched the use of all …
Source: Alabama Political Reporter - Center-left -
Published on Jun 24, 2025
Vivasure submits PerQSeal for FDA approval, expands indications in Europe
A screenshot of a video demonstrating the PerQSeal Elite in use. [Image from the Vivasure Medical website] Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA). Galway, …
Source: MassDevice - Neutral -
Published on Jun 24, 2025
Nuvalent closes in on FDA filing for lung cancer drug with topline Phase 1/2 data
Source: Endpoints News - Neutral -
Published on Jun 24, 2025
FDA Approves AstraZeneca And Daiichi Sankyo's Datroway For Type Of Lung Cancer
The Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc’s AZN Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior …
Source: Benzinga - Neutral -
Published on Jun 24, 2025
User fees from food companies could support FDA’s food safety programs
If the FDA charged food companies user fees it could strengthen its oversight of food safety, according to a recent study. The study, “Advancing the FDA’s Human Foods Program Through Additional Authorities and User Fees,” was published in the journal …
Source: Food Safety News - Neutral -
Published on Jun 24, 2025
Gland Pharma Ltd receives EIR from US FDA for JNPC Facility, Visakhapatnam
Gland Pharma Limited has announced that following the Pre-approval inspection (PAI) for Sterile APIs at the Company's Facility at JNPC, Visakhapatnam between February 19, 2025, and February 25, 2025; the Company has received Establishment Inspection …
Source: Equity Bulls - Neutral -
Published on Jun 24, 2025
FDA approves new blood test for diagnosing Alzheimer’s
June is Alzheimer’s and Brain Health Awareness Month. More than 7 million people have Alzheimer’s disease here in the United States. Now, a new blood test may be able to help with early diagnosis. “The new blood test that’s available for Alzheimer’s …
Source: WSLS - Virginia - Pending -
Published on Jun 24, 2025
FDA genAI reviews hinge on clarity of dossiers
Sponsors will need to ensure they are complying and submitting full, understandable dossiers if they are hoping to benefit from the US Food and Drug Administration’s (FDA’s) new generative artificial intelligence (genAI) submission assessment. Although the …
Source: Pharmaceutical Technology - Neutral