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Food and Drug Administration

Food and Drug Administration
Health / Medical / National

FDA Greenlights FluMist for Self- and Caregiver-Administration

September 24, 2024September 23, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved FluMist for self- or caregiver-administration, expanding accessibility for influenza prevention. FluMist, designed to combat influenza virus subtypes A and …

FDA Greenlights FluMist for Self- and Caregiver-Administration Read More

U.S. Food and Drug Administration
Health / Medical / National

FDA Approves Miplyffa for Niemann-Pick Disease, Type C

September 24, 2024September 23, 2024 - by Maryann Pugh

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
Food and Drug Administration
National

FDA Issues Draft Guidance on Multiregional Clinical Trials in Oncology

September 23, 2024September 23, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently unveiled a draft guidance designed to enhance multiregional clinical trials (MRCTs) in oncology, aimed at improving data relevance for …

FDA Issues Draft Guidance on Multiregional Clinical Trials in Oncology Read More

Baby Powder
National

Urgent Recall: Dynacare Baby Powder Pulled Over Asbestos Concerns

September 22, 2024September 21, 2024 - by Maryann Pugh

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
Bionpharma Inc. Issues Recall for Contaminated Atovaquone Oral Suspension
National

Your Safety First: What You Need to Know About Bionpharma’s Urgent Atovaquone Recall

September 20, 2024September 19, 2024 - by Maryann Pugh

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

iPhone with Airpods
Health / Medical / National

Revolutionary Hearing Aid Software Turns AirPods Pro into Accessible Hearing Solutions!

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

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
Food and Drug Administration
National

Lab Scandal Explodes: FDA Exposes Shocking Data Breaches and Animal Abuse at Chinese Testing Facilities!

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

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

Neuraptive Therapeutics
Products and Services

Neuraptive’s NTX-001 Secures Breakthrough Therapy Designation for Nerve Repair

September 18, 2024September 18, 2024 - by Timothy Alexander

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
Johnson & Johnson
Regional

FDA Approves TREMFYA® for Ulcerative Colitis Treatment, Promising New Hope for Patients

September 16, 2024September 15, 2024 - by Timothy Alexander

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
FDA Alerts Public to Recall of 7-Eleven Fudge Brownies Over Allergy Concerns
National

Your Safety First: Beware of Recalled 7-Eleven Brownies with Hidden Walnut Risks

September 12, 2024September 12, 2024 - by Maryann Pugh

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

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