Author name: admin22

EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and EISMEA’s Director Momchil Sabev signed a letter of intent to reinforce their continuing efforts in helping innovators better understand EU regulatory requirements and prepare health …

EMA and EISMEA boost cooperation to accelerate health innovations Read More »

FDA has approved Lipfendra (enlicitide) as a treatment to be used with diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol or who have an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).

On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least …

FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer Read More »

The U.S. Food and Drug Administration approved the first generic versions of GILOTRIF (afatinib tablets) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test; and treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.

On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment …

FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors Read More »

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 …

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

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.

EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available.

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 »

FDA published the proposed rule, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments.