FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 26, 2023 - 14:24 GMT

FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens

FDA News Release Draft Guidance Provides Examples of Ways Manufacturers Can Significantly Minimize or Prevent Allergen Cross-Contact and Undeclared Allergens For Immediate Release: September 26, 2023 Today, the U.S. Food and Drug Administration announced …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 22, 2023 - 20:22 GMT

FDA Roundup: September 22, 2023

For Immediate Release: September 22, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA and Sponsors …

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Published on September 19, 2023 - 20:13 GMT

FDA Roundup: September 19, 2023

For Immediate Release: September 19, 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 informed the public in the Prostate Cancer Symptoms, Tests and Treatments Consumer …

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Published on September 15, 2023 - 20:07 GMT

FDA Roundup: September 15, 2023

For Immediate Release: September 15, 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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar …

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Published on September 15, 2023 - 15:22 GMT

FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda

For Immediate Release: September 15, 2023 Today, the U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase …

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Published on September 12, 2023 - 15:04 GMT

FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products

FDA News Release Agency Warns Eight Companies Regarding Their Unapproved Ophthalmic Drugs For Immediate Release: September 12, 2023 The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing …

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Published on September 11, 2023 - 17:52 GMT

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

For Immediate Release: September 11, 2023 Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2023 - 16:59 GMT

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. …

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Published on September 11, 2023 - 14:28 GMT

FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in …

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Published on September 11, 2023 - 14:06 GMT

FDA Clears First COVID-19 Home Antigen Test

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2023 - 20:24 GMT

FDA Issues Warning Letters to Three Infant Formula Manufacturers

For Immediate Release: August 30, 2023 Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is …

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Published on August 29, 2023 - 19:15 GMT

FDA Roundup: August 29, 2023

For Immediate Release: August 29, 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 informed consumers in Treating and Dealing with ADHD about FDA-approved treatments …

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Published on August 25, 2023 - 20:03 GMT

FDA Roundup: August 25, 2023

For Immediate Release: August 25, 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 announced the signing of a first-of-its kind Regulatory Partnership Arrangement with …

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Published on August 24, 2023 - 21:21 GMT

FDA Approves First Biosimilar to Treat Multiple Sclerosis

For Immediate Release: August 24, 2023 The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). …

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Published on August 23, 2023 - 16:23 GMT

FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program

For Immediate Release: August 23, 2023 Today, the U.S. Food and Drug Administration is announcing the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. The new executive position will lead the charge in setting and …

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Published on August 21, 2023 - 21:46 GMT

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

For Immediate Release: August 21, 2023 Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and …

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Published on August 18, 2023 - 20:26 GMT

FDA Roundup: August 18, 2023

For Immediate Release: August 18, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA provided an update to the list of ultraviolet (UV) wand products that may present …

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Published on August 15, 2023 - 20:00 GMT

FDA Roundup: August 15, 2023

For Immediate Release: August 15, 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 announced a request for information on a citizen petition asking the FDA to amend the …

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Published on August 13, 2023 - 23:59 GMT

FDA Roundup: August 11, 2023

For Immediate Release: August 11, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued an Outbreak Advisory for an investigation of Listeria monocytogenes …

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Published on August 12, 2023 - 14:10 GMT

FDA Roundup: December 8, 2023

For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certain PMA …

Distribution channels: Healthcare & Pharmaceuticals Industry