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FDA Issues Final Guidance About Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs

The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This guidance provides recommendations to industry on formal meetings between the FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs or organizations nominated by sponsors or requestors to represent …

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FDA publishes the final guidance for industry, “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence”

On July 13, 2026, FDA published the final guidance for industry titled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products (topical corticosteroids) and describes recommendations for in vivo studies to demonstrate the bioequivalence (BE) of topical corticosteroids.

FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This …

FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer Read More »