FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Adamis Gains Zimhi OK for Opioid Overdose

[ Price : $8.95]

FDA approves an Adamis Pharmaceuticals NDA for Zimhi (naloxone HCl injection, 5 mg/0.5 mL) for treating opioid overdose.

Melinta Raises Covid-Related Issue with Nexus ANDA

[ Price : $8.95]

Melinta Therapeutics says it did not receive a Nexus Pharmaceuticals Paragraph 4 certification for a generic form of Melintas Mino...

Sprint Nerve Stimulator Gains Broader Indication

[ Price : $8.95]

FDA clears an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation System head, n...

Oyster Point Nasal Spray for Dry Eye OKd

[ Price : $8.95]

FDA approves an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of ...

FDA Warns 2 Physician Researchers

[ Price : $8.95]

FDA warns two Hennepin County Medical Center researchers they failed to submit INDs for their clinical investigations.

Sen. Blumenthal Likely to Oppose Califf Nomination

[ Price : $8.95]

Sen. Richard Blumenthal (D-CT) tells a Bloomberg News reporter that he will likely oppose Duke University School of Medicine profe...

CGMP Deviations at Marcus Research Laboratory

[ Price : $8.95]

FDA warns Marcus Research Laboratory about CGMP deviations in its production of active pharmaceutical ingredients.

CGMP Violations at Sircle Laboratories

[ Price : $8.95]

FDA warns Sircle Laboratories about CGMP violations in its production of finished drugs.

Akero Gains Fast Track for NASH Drug

[ Price : $8.95]

FDA grants Akero Therapeutics a fast track designation for efruxifermin and its use in treating non-alcoholic steatohepatitis (NAS...

Revance BLA Shot Down Over Inspection Findings

[ Price : $8.95]

FDA sends Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection, indicated for treating...