FoodNavigator

From lab to table: How different markets regulate novel foods

Novel foods represent the cutting edge of food innovation. Foods like cultivated meat and insect protein are often completely new to consumers. While this arguably makes them more exciting, it also ...
Monthly Prescribing Reference

Novel Low-Sodium Oxybate Formulation Under FDA Review

The FDA has set a Prescription Drug User Fee Act target date of June 20, 2026 for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for TRN ...
Morningstar

Kelun-Biotech's novel ADC drug SKB518 has been granted the clearance of IND from the United States Food and Drug Administration (FDA)

CHENGDU, China, April 21, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has been granted the clearance of investigational new drug ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...