FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx ...
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a ...
STAT15d
Q&A: How the FDA is approaching AI in clinical trials and drug development
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.
Food & Wine25d
The FDA Is Launching New Traceability Rules for Added Food Safety — and Everyone Is Confused
On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules — dubbed the Food Traceability Final Rule — will go into effect. The rule, the FDA explained, "establishes ...
Islander News12h
Block production of compounded Ozempic, drug maker asks FDA
This week, Novo Nordisk, the Copenhagen, Denmark based pharmaceutical company, asked the US Food and Drug Administration (FDA ...
US FDA expands use of Avadel's sleep disorder drug to ages 7 and up
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...
Food Safety News5d
FDA updates food import alerts for unapproved drugs, heavy metals and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
NBC Chicago28d
FDA issues recall notices over 2 brands of pet food due to salmonella and listeria risk
Amid an ongoing pet food recall, the U.S. Food and Drug Administration (FDA) is urging pet owners not to give their dogs and ...
FOX8 Cleveland29d
Dog food pulled from shelves nationwide: FDA
(WJW) – The U.S. Food and Drug Administration reports a pet food company ... ANSWERS has provided a picture of the products, here. The FDA recommends any product from the listed lots should ...
Austin American-Statesman24d
FDA issues recalls on at least 16 food and drug items in September. Here's a list
This could be due to U.S. Food and Drug Administration recalls. The FDA has continued to suspend food and drug items that people might typically buy. Here is a list of September food and drug ...
Business Wire27d
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of ...
today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.
Telix Pharmaceuticals Limited: FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has ...