FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts ImmunityBio BLA

[ Price : $8.95]

FDA sets 5/23/23 as the target PDUFA action date for its review of ImmunityBios N-803 to treat some bladder cancers.

Lexicon Re-files NDA for Heart Failure Drug

[ Price : $8.95]

FDA accepts for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhib...

Cannabis Administration and Opportunity Act

[ Price : $8.95]

Senate leaders introduce the Cannabis Administration and Opportunity Act.

Breakthrough Designation for Vertex Pain Drug

[ Price : $8.95]

FDA grants breakthrough therapy designation to Vertex VX-548 for some acute and neuropathic pain indications.

Objectionable Conditions in Goodman Eye Center Trial

[ Price : $8.95]

FDA warns Dr. Daniel Goodman about objectionable conditions in a clinical trial at his San Francisco, CA-based Goodman Eye Center.

Neonatal Study Pharmacology Considerations

[ Price : $8.95]

FDA publishes a guidance to help drug sponsors who are planning to conduct clinical studies in neonatal populations.

Guide on LASIK Patient Labeling Recommendations

[ Price : $8.95]

FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly comm...

Ivax Pharmas Chloramphenicol Withdrawn Over Safety

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the c...

Info Collection on Pharma Consensus Standards

[ Price : $8.95]

Federal Register notice: FDA sends to OMB a new information collection entitled Pharmaceutical Voluntary Consensus Standard Recogn...

Cassava Sciences Under Criminal Investigation: Reuters

[ Price : $8.95]

Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manip...