FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 14, 2023 - 19:05 GMT

Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

For Immediate Release: December 14, 2023 The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 14, 2023 - 16:05 GMT

FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals

For Immediate Release: December 14, 2023 Today, the U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law …

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Published on December 14, 2023 - 16:05 GMT

Joint Federal Operation Results in Seizure of More Than $18 Million in Illegal E-Cigarettes

For Immediate Release: December 14, 2023 Today, the U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), announced the seizure of approximately 1.4 million units of unauthorized e-cigarette products, including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 13, 2023 - 18:03 GMT

FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts

FDA News Release Additional Changes Showcase Agency-wide Impact of Proposal For Immediate Release: December 13, 2023 Today, the U.S. Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program (HFP) and new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 12, 2023 - 15:00 GMT

FDA Creates New Advisory Committee for Evaluation of Genetic Metabolic Disease Treatments

For Immediate Release: December 12, 2023 Today, the U.S. Food and Drug Administration announced it is creating a new advisory committee related to potential treatments for genetic metabolic diseases. Genetic metabolic diseases are conditions that disrupt …

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Published on November 28, 2023 - 21:38 GMT

FDA Roundup: November 28, 2023

For Immediate Release: November 28, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam …

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Published on November 28, 2023 - 20:56 GMT

FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines

For Immediate Release: November 28, 2023 Today, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 27, 2023 - 23:32 GMT

FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors

For Immediate Release: November 27, 2023 Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for …

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Published on November 21, 2023 - 21:14 GMT

FDA Roundup: November 21, 2023

For Immediate Release: November 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a safety communication to provide additional information about the voluntary …

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Published on November 17, 2023 - 21:40 GMT

FDA Roundup: November 17, 2023

For Immediate Release: November 17, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with …

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Published on November 16, 2023 - 15:48 GMT

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature ...

For Immediate Release: November 16, 2023 Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products …

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Published on November 15, 2023 - 20:53 GMT

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection

FDA News Release Today’s Action also Opens the 510(k) Pathway for Other Tests for These Infections with At-Home Sample Collection For Immediate Release: November 15, 2023 Today, the U.S. Food and Drug Administration granted marketing authorization to …

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Published on November 15, 2023 - 20:40 GMT

Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs

For Immediate Release: November 15, 2023 Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its chief executive …

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Published on November 14, 2023 - 20:41 GMT

FDA Roundup: November 14, 2023

For Immediate Release: November 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA updated the advisory for the Investigation of Elevated Lead Levels in Cinnamon …

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Published on October 31, 2023 - 22:11 GMT

FDA Roundup: October 31, 2023

For Immediate Release: October 31, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting …

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Published on October 31, 2023 - 22:11 GMT

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

For Immediate Release: October 31, 2023 Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is …

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Published on October 27, 2023 - 20:53 GMT

FDA Roundup: October 27, 2023

For Immediate Release: October 27, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) Director Brian King published a statement summarizing …

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Published on October 26, 2023 - 15:22 GMT

FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

For Immediate Release: October 26, 2023 As part of the U.S. Food and Drug Administration’s commitment to protecting public health, the agency is advising the public, including healthcare providers, of the possible risks that products containing live …

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Published on October 24, 2023 - 20:17 GMT

FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes

For Immediate Release: October 24, 2023 Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 ( …

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Published on October 24, 2023 - 18:52 GMT

FDA Roundup: October 24, 2023

For Immediate Release: October 24, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA approved Medtronic’s Aurora EV-ICD System for the treatment of patients who have …

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