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WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Miplyffa (arimoclomol) for the treatment of Niemann-Pick disease, type C (NPC), marking the first drug sanctioned to address …
FDA Approves Miplyffa for Niemann-Pick Disease, Type C Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently unveiled a draft guidance designed to enhance multiregional clinical trials (MRCTs) in oncology, aimed at improving data relevance for …
FDA Issues Draft Guidance on Multiregional Clinical Trials in Oncology Read More
WASHINGTON, D.C. — In a recent announcement by the Food and Drug Administration, Dynarex Corporation has initiated a recall of 62 cases of its Dynacare Baby Powder due to potential …
Urgent Recall: Dynacare Baby Powder Pulled Over Asbestos Concerns Read More
WASHINGTON, D.C. — Bionpharma Inc. this week announced a voluntary recall of a single batch of Atovaquone Oral Suspension, 750mg per mL, due to contamination with Cohnella bacteria. This recall, …
Your Safety First: What You Need to Know About Bionpharma’s Urgent Atovaquone Recall Read More
WASHINGTON, D.C. — In a groundbreaking move aimed at enhancing accessibility and innovation in hearing aid technology, the U.S. Food and Drug Administration (FDA) recently authorized the first over-the-counter (OTC) …
Revolutionary Hearing Aid Software Turns AirPods Pro into Accessible Hearing Solutions! Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently issued warning letters to two Chinese nonclinical testing laboratories. The letters, sent to Mid-Link Testing Company Ltd. in Tianjin …
Lab Scandal Explodes: FDA Exposes Shocking Data Breaches and Animal Abuse at Chinese Testing Facilities! Read More
CHESTERBROOK, PA — Neuraptive Therapeutics, Inc. has announced that its investigational therapy, NTX-001, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is poised to …
Neuraptive’s NTX-001 Secures Breakthrough Therapy Designation for Nerve Repair Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has announced the FDA‘s approval of TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). This chronic inflammatory condition affects …
FDA Approves TREMFYA® for Ulcerative Colitis Treatment, Promising New Hope for Patients Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a voluntary recall by Innovation Bakers, LLC, based in Fullerton, California, involving one day’s production of its 3.5 oz …
Your Safety First: Beware of Recalled 7-Eleven Brownies with Hidden Walnut Risks Read More
WASHINGTON, D.C. — The National Youth Tobacco Survey (NYTS) has revealed a substantial decline in e-cigarette usage among the youth in the United States. According to the latest data disclosed …
Youth Vaping Drops Dramatically: Uncovering the Forces Behind the Decline and Remaining Challenges Read More