Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

Stockholm, Sweden, December 19, 2025. Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (NASDAQ Stockholm: EGTX), today announced that the Company has initiated a rolling New Drug Application ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Self-represented prisoners face significant disadvantages when seeking justice through conviction integrity units, with some ...

Discover how drugs prevent, cure, and alleviate ailments. Learn about over-the-counter vs. prescription drugs and the ...

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...

Frits Stulp, Implement Consulting, says AI and global collaboration are key to addressing patent cliffs and accelerating ...

Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster ...

Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels ...

President Donald Trump signed an executive order Thursday that brings the U.S. closer to reclassifying marijuana as a less ...

President Donald Trump has directed his administration to pursue reclassifying marijuana as a less dangerous drug ...