Psychiatry Advisor

Novel Low-Sodium Oxybate Formulation Under FDA Review

Pharmacokinetic and safety studies were analyzed to demonstrate the safety and efficacy of TRN-257, as well as previous research on oxybate products.
KCUR

Feds seized thousands of 7-OH drug products from Kansas City warehouses

The FDA sent warning letters in June to the facility owners, Shaman Botanicals LLC and Relax Relief Rejuvenate Trading LLC, ...
KOIN

Oregon recalls select hemp pre-rolls due to excessive THC levels

Oregon alcohol and cannabis regulators are warning consumers that a number of hemp pre-rolls may have accidentally been sold ...
Targeted Oncology

FDA Grants Full Approval to Tarlatamab in Small Cell Lung Cancer

Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...
Targeted Oncology

FDA Approves Sevabertinib in HER2-Mutated Nonsquamous NSCLC

Sevabertinib received accelerated FDA approval for HER2 TKD-mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO-01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as ...
The Business Journals

Gene therapy invented at Children's gets strongest FDA label after patient deaths

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...
Federal Register

Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...