FDA’s food safety head resigns over mass layoffs
Jim Jones, the head of the Food and Drug Administration’s (FDA) food division, resigned Monday, citing the mass firings of ...
Senate Democrats press HHS over FDA firings
In letter, senators say recent staff firings could affect drug and device approval, food safety and public health threats.
PharmiWeb5d
Cambridge Cognition submits FDA Letter of Intent for Cognitive Impairment Assessments in Schizophrenia
Cambridge Cognition (AIM: COG), the brain health software group specialising in digital products to advance clinical research and patient treatment, has submitted a Letter of Intent to the U.S. Food ...
The Scranton Times-Tribune5d
Letter: Local case shows FDA should ban kratom
Her daughter died from mitragynine toxicity that is contained in Kratom. This powerful drug is being sold in tobacco stores all over as an herb. That is a joke. Everyone who buys it knows that it ...
Yahoo Finance3d
FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage
February 19, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access ...
Bloomberg L.P.4d
Food Head at FDA Resigns, Citing Numerous Job Cuts
Jim Jones, the head of the food division at the US Food and Drug Administration who oversaw ... chemicals in food,” he said in a resignation letter to Acting FDA Commissioner Sara Brenner.
FiercePharma3d
FDA disrupts Harmony's expansion dreams for excessive sleepiness drug Wakix with refusal letter
The FDA promptly shot down the company’s bid for an EDS with idiopathic hypersomnia (IH) indication with a Refusal to File (RTF) letter after a missed phase 3 study. While Wakix (pitolisant ...
Nasdaq3d
Harmony Biosciences Receives FDA Refusal To File Letter For Pitolisant In Idiopathic Hypersomnia
(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) Wednesday said that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the ...
Pharmabiz3d
Maharashtra FDA to address regulatory gaps for strengthening compliance and quality
In a decisive push to enhance drug regulatory compliance, the Maharashtra Food and Drug Administration (FDA) is aggressively working to address critical manpower shortages. Of the 200 sanctioned drug ...