FDA Related News

Human Drugs

Takeda Gains Expanded Approval for Gattex

FDA approves a Takeda Pharmaceuticals supplemental NDA to expand Gattexs (teduglutide) for injection to pediatric patients aged one year and older wit...

Medical Devices

Carefusion Paying $3.3 Million For Fraud Charges

The Justice Department says Carefusion is paying $3.3 million to resolve False Claims Act charges that it bought and sold uncleared and unapproved med...

Advancing Use of Patient-Reported Outcomes

Researchers suggest priorities needed to increase the use of patient-reported outcomes as data in real-world evidence.

Human Drugs

FDA OKs Combo Drugs for Kidney Cancer

FDA approves an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizers Inlyta (axitinib) for the first-line treatment of patien...

Human Drugs

Pfizer sNDA Approved for Pediatric-use Fragmin

FDA approves a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism in pe...

Medical Devices

Ethicon Recalls Endo-Surgery Intraluminal Staplers

Ethicon recalls its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler wi...

Human Drugs

Drug Development Landscape Evolving

Iqvia Institute identifies and analyzes trends in drug research and development in the next five years.

Human Drugs

FDA Part of Generic Drug Bioinformatics Research

University of Florida and Office of Generic Drugs researchers are developing a bioinformatics approach to evaluating bioinequivalence reports on gener...

Medical Devices

Masimo Radius PPG Tetherless Sensor Cleared

FDA clears a Masimo 510(k) for the Radius PPG, a tetherless sensor associated with the Masimo SET patient monitor.

Medical Devices

FDA Clears GenePOC Carba Assay

FDA clears a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms.