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FDA Roundup: May 7, 2024
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30 results for www.fda.gov:
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FDA approves Roctavian, the first gene therapy for treatment of adults with severe hemophilia A
Recall of Everest Brand Sambhar Masala and Garam Masala in the U.S. Due to Possible Health Risk - FDA.gov
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Everest Food Products Private Limited of Gujarat, India has been notified by FDA that samples
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The FDA approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy.
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The FDA approved the first drug for the prevention of RSV lower respiratory tract disease
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The U.S. Food and Drug Administration approved the second naloxone nasal spray product available without
FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers - FDA.gov
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FDA announces pilot program for certain oncology drug products used with certain tests to help
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The FDA has selected James “Jim” Jones to serve as the first Deputy Commissioner for
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FDA has approved the first biosimilar to Tysabri (natalizumab) injection for the treatment of relapsing
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FDA issues warning letters for unapproved ophthalmic drug products
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests - FDA.gov
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Today, the U.S. Food and Drug Administration announced a proposed rule Aimed at Helping to
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies - FDA.gov
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The FDA is announcing a pilot program aimed to help further accelerate the development of
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types - FDA.gov
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FDA grants marketing authorization for a test that can help detect hundreds of genetic variants
FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders - FDA.gov
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The FDA published a new draft guidance related to clinical trials for development of therapies
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FDA announces new Digital Health Advisory Committee to help the agency explore issues related to
FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants - FDA.gov
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The agency is advising the public, including healthcare providers, of the possible risks that probiotic
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The FDA approved Wezlana as an interchangeable biosimilar to Stelara for multiple inflammatory diseases.
FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder - FDA.gov
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The FDA approved Adzynma indicated for prophylactic or on demand enzyme replacement therapy in patients
CF Dallas, LLC, in Coordination with Sofia Produce, LLC Dba Trufresh, Voluntarily Recalls Select Fresh-Cut Fruit Products Due to Possible Salmonella Contamination - FDA.gov
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CF Dallas, LLC is voluntarily recalling select fresh-cut products made from whole cantaloupe subject
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The FDA approved Ogsiveo tablets for adult patients with progressing desmoid tumors who require systemic
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The FDA is alerting the public about an emerging safety issue involving Philips Respironics’ DreamStation
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The FDA approved Lantidra, the first cellular therapy for the treatment of adults with type
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The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment
Joint Federal Operation Results in Seizure of More Than $18 Million in Illegal E-Cigarettes - FDA.gov
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Today, the FDA, in collaboration with CBP, announced the seizure of approximately 1.4 million units
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity - FDA.gov
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Preliminary evaluation does not suggest a causal link
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices - FDA.gov
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ResMed Ltd. recalls AirFit & AirTouch masks due to possible magnetic interference with certain medical devices
Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk - FDA.gov
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Rizo-López Foods, Inc. (“RLF”) is voluntarily recalling its dairy products listed below because
FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease - FDA.gov
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The FDA approved the first medication, to be used along with diet and exercise, for
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Lenmeldy is the first FDA-approved gene therapy to treat children with metachromatic leukodystrophy (MLD
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shares fell more than 6% on Wednesday after the U.S. Food and Drug Administration <a href="https://www.fda.gov/medical-devices/safety-communications/carefully-moni