The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development. “Since these products are ...
The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance ...
At a time when many basic living expenses are rising, generic medicines play a critical role in expanding access to safe, ...
Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, marking a ...
DifGen Pharmaceuticals shared that its partner, Apotex recently received approval from the Food and Drug Administration for nintedanib soft gel capsules, 100 mg and 150 mg, which is the generic of ...
The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the ...
MIRAMAR, Fla., March 11, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has ...
WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application ...
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