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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 an …
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 …
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 …
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 ( …
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.
Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance is intended to provide information about FDA inspections of clinical …
Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance is intended to provide information about FDA inspections of Institutional …
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 View Product Photos …
On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of …
STN# 125673 Proper Name: Procleix Babesia Assay Tradename: Procleix Babesia Assay Manufacturer: Grifols Diagnostics Solutions Inc. Indication: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA …
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.
This list includes cleared 510(k) submissions for 2025 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change. The clearances are …
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