FDA Approval Database

FDA, drugmaker Blujepa

FDA approves first new UTI drug in decades

The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug approved in decades and the first in a new class of medications. British

Medical Xpress · 3d

FDA approves new drug to treat heart conditions

The U.S. Food and Drug Administration (FDA) has approved a new drug for a serious heart condition that affects thousands of people.

Markets Insider · 1d

Soleno Therapeutics announces FDA approval of VYKAT XR to treat hyperphagia

Soleno Therapeutics (SLNO) “announced that the FDA has approved VYKAT XR, diazoxide choline, extended-release tablets, previously referred to

FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance

The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable ...

15h

Soleno Shares Soar Premarket on FDA Approval of Vykat XR

Soleno on Wednesday said the FDA approved its Vykat XR extended-release tablets for the treatment of hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, in people ages 4 ...

FDA grants 510(k) clearance for Huntleigh’s CTG Analysis

The Dawes-Redman CTG Analysis is designed to assess if a non-stress test trace meets the “criteria of normality".

News Medical on MSN23h

Cabozantinib gains FDA approval for treating advanced neuroendocrine tumors

Cabozantinib, an oral tyrosine kinase inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated advanced neuroendocrine tumors ...

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