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Food and Drug Administration

Copycat Delta-8 THC Food Products
National

FDA and FTC Crack Down on Illegal Delta-8 THC Copycat Products

July 19, 2024July 18, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters to five companies for selling illegal copycat food products containing …

FDA and FTC Crack Down on Illegal Delta-8 THC Copycat Products Read More

Food and Drug Administration
National

FDA Revises Guidance on User Fees for Combination Products

July 19, 2024July 18, 2024 - by Maryann Pugh

WASHINGTON, D.C. — On Tuesday, the Food and Drug Administration (FDA) issued updated guidance on the application user fees for combination products. This revised document aims to clarify how fees …

FDA Revises Guidance on User Fees for Combination Products Read More
FDA
Infectious Diseases / National

FDA Approves Rapid Test to Combat Deadly Candida Auris

July 19, 2024July 18, 2024 - by Timothy Alexander

WASHINGTON, D.C. — On Monday, the Food and Drug Administration (FDA) approved a new diagnostic test designed to detect Candida auris (C. auris) DNA from skin swabs. This test, developed …

FDA Approves Rapid Test to Combat Deadly Candida Auris Read More

Food and Drug Administration
National / Pediatrics

FDA Issues New Guidance on Epilepsy Drugs for Young Children

July 19, 2024July 18, 2024 - by Maryann Pugh

WASHINGTON, D.C. — On Monday, the Food and Drug Administration (FDA) released new guidelines aimed at improving treatment options for young children with partial onset seizures (POS). The guidance, titled …

FDA Issues New Guidance on Epilepsy Drugs for Young Children Read More
Globus Medical
Regional

Globus Medical Gains FDA Clearance for New Knee Surgery Technology

July 18, 2024July 17, 2024 - by Timothy Alexander

AUDUBON, PA — Globus Medical, Inc. (NYSE: GMED) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ExcelsiusFlexâ„¢ robotic navigation platform, tailored for Total Knee …

Globus Medical Gains FDA Clearance for New Knee Surgery Technology Read More

Annovis Bio
Medical Products

Annovis Bio Gains FDA Approval for New Form of Neurodegenerative Drug

July 17, 2024July 16, 2024 - by Timothy Alexander

MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future …

Annovis Bio Gains FDA Approval for New Form of Neurodegenerative Drug Read More
Passage Bio
Health / Medical / Regional

Passage Bio Receives FDA Support for Expanding Dementia Treatment Trial

July 17, 2024July 16, 2024 - by Timothy Alexander

PHILADELPHIA, PA — Passage Bio, Inc. (NASDAQ: PASG) announced positive feedback from the U.S. Food and Drug Administration (FDA) on its proposal to evaluate PBFT02 for treating frontotemporal dementia (FTD) …

Passage Bio Receives FDA Support for Expanding Dementia Treatment Trial Read More

U.S. Food and Drug Administration
National

FDA Warns Healthcare Providers of Blood Culture Media Bottle Shortage

July 14, 2024July 14, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has notified healthcare providers about a significant disruption in the supply of BD BACTEC blood culture media bottles, a crucial tool …

FDA Warns Healthcare Providers of Blood Culture Media Bottle Shortage Read More
U.S. Food and Drug Administration (FDA)
National

FDA Issues New Guidelines for Devices Treating Opioid Use Disorder

July 14, 2024July 14, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has released new guidelines aimed at improving the design of clinical studies for devices that treat opioid use disorder (OUD). This …

FDA Issues New Guidelines for Devices Treating Opioid Use Disorder Read More
Cat
National

FDA Approves First Generic Methimazole Oral Solution for Cats

July 14, 2024July 14, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently approved Felanorm, the first generic methimazole oral solution for treating hyperthyroidism in cats. This new medication offers a vital …

FDA Approves First Generic Methimazole Oral Solution for Cats Read More

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