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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 ...
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 ...
Pharmacy benefit managers will face new regulations under an Iowa law aimed to prevent pharmacy closures and help financially struggling pharmacies.
The attorneys general of New York, California, Massachusetts and New Jersey asked the Food and Drug Administration to expand ...
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 ...