Thursday, March 28, 2024

Thursday, March 28, 2024

Latest News

FDA: Releases Report on Investigation into Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce

As the nation grapples with the COVID-19 public health emergency, the U.S. Food and Drug Administration is grateful for all that the food and agricultural sector is doing to provide safe and available food to consumers during this difficult time.

FDA: Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test

The U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19.

FDA: Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.

SIMULATIONS PLUS: U.S. FDA Renews Annual DILIsym Software Licenses

DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has again renewed its multi-seat license for the company’s leading quantitative systems toxicology (QST) modeling software, DILIsym®.

ALUME BIOSCIENCES: US FDA Allows Trial to Proceed for Alume Biosciences' Nerve Imaging Candidate

Phase 1/2 Clinical Trial for ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery Will Begin Enrollment at the University California San Diego (UCSD), Stanford and Harvard

ALPHA COGNITION, INC.: Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Alpha Cognition Inc. (ACI) today announced that in a pre-Investigational New Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clinical and regulatory pathway for the approval of Alpha-1062, a patented new chemical entity, to treat Alzheimer's disease.

ANI: Receives Refusal to File Letter from FDA for Cortrophin® Gel

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Cortrophin® Gel.

CARIS LIFE SCIENCES: Submits Two PMA Applications to the FDA for Whole Exome and Whole Transcriptome Sequencing

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the submission of two Pre-Market Approval (PMA) applications for MI Exome™ CDx and MI Transcriptome™ CDx to the U.S. Food and Drug Administration (FDA).

FDA: Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

The U.S. Food and Drug Administration announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.

BD: Announces Second FDA Emergency Use Authorization, CE Mark for New COVID-19 Molecular Diagnostic for Global Use

New Test Uses BD MAX™ System to Augment Supply from Existing Collaborations; Test Results in Under Three Hours

FDA: Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators

The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings.

BIOHAVEN: To Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA

In previously reported positive topline results from pivotal Phase 2/3 clinical trial in December 2019, vazegepant achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours

FDA: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.

FDA: Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements

U.S. Food and Drug Administration took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.

FDA Reporter