Dublin, May 26, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance ... operations to align with evolving US, EU, and UK compliance standards and ...

New Drug Submission filed by Lipocine's licensing partner Verity Pharma <li /> Over 700,000 total prescriptions written annually for test ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in ...

We thank the agency for its guidance and a constructive dialogue over the past seven years, which has been crucial in helping us ... filing. With a scientific bridge established upon review, CTx-1301 ...

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

The attorneys general of New York, California, Massachusetts and New Jersey asked the Food and Drug Administration to expand ...

May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build ...

Available data for nonclinical safety appears adequate to support a filing. With a scientific bridge established upon review, CTx-1301 may rely on the efficacy and safety data of the listed drug ...

According to Duffy, the deregulatory package will rescind, withdraw, or amend regulations that do not enhance safety.