FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Announces 7 Info Collections Approved

[ Price : $8.95]

Federal Register notice: FDA announces that seven information collections have been approved by OMB.

Astria Gets Fast Track for Angioedema Drug

[ Price : $8.95]

FDA grants Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema.

FDA OKs Vanflyta for Leukemia

[ Price : $8.95]

FDA approves a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia.

New FDA Tools in Democrats Preparedness Bill

[ Price : $8.95]

All Democrats on the House Energy and Commerce Committee sponsor legislation to reauthorize the Pandemic and All-Hazards Preparedn...

Dont Use Quidel Triage Cardiac Panel: FDA

[ Price : $8.95]

FDA says healthcare providers, laboratories, and facilities should immediately stop using the Quidel Triage Cardiac Panel due to i...

Ex-FDA Gene Therapy Guru Joins Greenleaf

[ Price : $8.95]

Former CBER Office of Tissues and Advanced Therapies director Wilson Bryan joins regulatory consulting firm Greenleaf Health as e...

8 Repeat QS Violations at Edge Biologicals

[ Price : $8.95]

FDA warns Memphis, TN-based Edge Biologicals about eight repeated Quality System violations in its manufacturing of in vitro diagn...

Ambrx Gets Fast Track for Prostate Cancer Drug

[ Price : $8.95]

FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant ...

Nitric Oxide Delivery Device Recalled

[ Price : $8.95]

NOxBOX recalls its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the devices manifold.

FDA Clears ReddyPort Ventilation Device

[ Price : $8.95]

FDA clears the ReddyPort elbow device used in non-invasive ventilation.