FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

VAI Close Out for HLB Inspection

[ Price : $8.95]

A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facili...

Kennedy Wanted Sentinel, BEST Data: Reuters

[ Price : $8.95]

A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides a...

Priority Review for Gazyva sBLA for Primary Membranous Nephropathy

[ Price : $8.95]

FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with pr...

Axsome NDA for Cataplexy in Patients with Narcolepsy

[ Price : $8.95]

FDA accepts for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy.

CGMP Issues Found at International Medication Systems

[ Price : $8.95]

FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.

Multiple Violations in ZIIP Inspection

[ Price : $8.95]

FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unappr...

Biogen Defends Anti-Tau Alzheimer's Data After Investor Selloff

[ Price : $8.95]

Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promi...

Keep Safety and Dosing Info in Valtoco Label: Petition

[ Price : $8.95]

Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco f...

Pallone Asks GAO to Analyze RIF Impact on User Fees

[ Price : $8.95]

House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid...

Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

[ Price : $8.95]

A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory co...