Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-24 Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-24 December 8, 2025 Dear Mr. Hamza: The United States Food and Drug …
STN# 125317 Proper Name: Fibrinogen Concentrate (Human) Tradename: RIASTAP Manufacturer: CSL Behring GmbH Indication: Treatment of of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia …
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The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
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 …
Action The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Disease or Condition Symptomatic oHCM is …
Action The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. Accrufer was initially approved in 2019 for adults with iron deficiency. Disease or Condition …
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 …
AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa …
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
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 …
Action Today, the U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). Jascayd was previously approved to treat idiopathic pulmonary fibrosis (IFP) in adults. Disease or …
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: December 19, 2025 The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase …
[December 19, 2025] The U.S. Food and Drug Administration (FDA) today qualified total hip bone mineral density (BMD) as assessed by dual energy X-ray absorptiometry (DXA) as a validated surrogate endpoint to support clinical trials of investigational …
Bavencio (avelumab) Imfinzi (durvalumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Cardiac failure FDA decided that no action is necessary at this time based on available information. Invega Sustenna (paliperidone palmitate) Invega Trinza ( …
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