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The U.S. Food and Drug Administration (FDA) granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection to reduce proteinuria (protein in the urine) in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Delivery Method: VIA Electronic Mail Reference #: 320-26-11 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Dr. Donald R. Owen Recipient Title Chief Executive Officer Owen Biosciences, Inc. 7053 Revenue Drive Baton Rouge, LA 70809-4918 …
Delivery Method: VIA Electronic Mail Product: Drugs Recipient: VarunKart Group LLC dba Organic Wellnesses 8206 Louisiana Blvd NE, STE A #4959 Albuquerque, NM 87113 United States support@organicwellnesses.com Issuing Office: Center for Drug Evaluation and …
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 17, 2025 RE: 716286 Mahesh Chada: This letter is to advise you that the U.S. Food and Drug Administration (FDA) …
Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Bassem W. Girgis Recipient Title President Northern VA Compounders PLLC, dba Akina Pharmacy 23475 Rock Haven Way, Suite 105 Sterling, VA 20166-4444 United States Issuing Office: …
ACTIONS BY MONTH Oct-24 Nov-24 Dec-24 Jan-25 Feb-25 Mar-25 Apr-25 May-25 Jun-25 Jul-25 Aug-25 Sep-25 FY-2025 Approvals 62 58 67 63 53 54 62 64 67 52 47 40 689 First-Time Generics 6 4 8 9 6 10 7 17 9 5 8 3 92 First-Cycle Approvals 8 14 11 11 6 9 19 9 18 9 9 …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
The Office of Pharmaceutical Quality (OPQ) reviews correspondence from generic drug manufacturers and related industry or their representatives related to generic drug development (i.e., controlled correspondence submissions) requesting information …
On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
For Immediate Release: November 19, 2025 The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting Minute …
On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL …
On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
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