Drug approvals, label changes, and FDA drug news.
Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop.
Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive and less accessible to the patients who need them.
If we want more nurses, we need more nursing students, which means creating the educational infrastructure needed to help them succeed. The post To Solve the Nursing Shortage, Our Leaders in Washington Must Invest in Higher Education appeared first on MedCity News .
Washing your hands is one of the most important things you can do to avoid getting sick and spreading germs to people around you. The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water.
FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions.
This Memorandum of Understanding ("MOU") between the U.S. Department of Health and Human Services (HHS), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Veterans Affairs (VA) (hereafter “the Parties” or “Federal Partners”) provides a framework for collaboration and the exchan
Psychedelic Drugs: Considerations for Clinical Investigations
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
Efficacy supplement (new or revised indication). injectable, subcutaneous. Sponsor: Eisai Inc
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Eli Lilly And Co
Pharma platform company China Medical System Holdings has tapped up existing partner Insilico for a 1.2 billion yuan ($177 million) collaboration aimed at a “mass-market” central nervous system indication.
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
CDER proposes to withdraw approval of TAVNEOS
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 adjuvan
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model.
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
Original new drug approval. solution, intravenous, interstitial. Sponsor: Provepharm Sas
Efficacy supplement (new or revised indication). solution, intravenous. Sponsor: Merck Sharp Dohme
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Merck Sharp Dohme
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Astellas
The FDA is taking decisive steps to strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines.
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.