In a regulatory milestone, the FDA clears AuraWell’s PEMF technology as the first over-the-counter frequency therapy device for at-home recovery.
LIBERTY is part of the Company’s broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated ...
The US health department’s inspector general is investigating whether a top US Food and Drug Administration official misled the federal government by using a sham divorce to avoid running afoul of ...
Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...
FDA officials are advising drug developers to study the long-term effects of using CAR-T in autoimmune conditions, out of ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
Federal health officials are investigating a multi-state outbreak of two strains of salmonella connected to two recalled supplementary powders.
On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...
Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.
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