FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Clinical Hold on Sigilon Hemophilia Study

[ Price : $8.95]

FDA places a clinical hold on a Sigilon Therapeutics Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemop...

Bayers Kerendia Approved for Diabetes Patients

[ Price : $8.95]

FDA approves Bayers Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular de...

Final Approval Granted for Astellas Padcev

[ Price : $8.95]

FDA grants full approval to Astellas Pharma for Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inh...

HHS Withdraws Insulin Reimportation Notice

[ Price : $8.95]

Federal Register notice: HHS withdraws a 1/21 notice entitled Requests for Proposals for Insulin Reimportation and Personal Prescr...

BCC May Contaminate Some Water-Based Drugs: FDA

[ Price : $8.95]

FDA says manufacturers of non-sterile water-based drugs should take steps to guard against contamination from Burkholderia cepacia...

Regulatory Review Period for Piqray

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Piqray (alpelisib)...

FDA, Biogen Yield to Critics on Alzheimers Label

[ Price : $8.95]

FDA approves a Biogen labeling amendment that narrows the indication for its controversial Alzheimers therapy Aduhelm (aducanumab)...

FDA Warning on NuVasives Precise Implants

[ Price : $8.95]

FDA alerts health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precic...

AstraZeneca Asthma Priority BLA Accepted

[ Price : $8.95]

FDA accepts for priority review an AstraZeneca BLA for tezepelumab for treating asthma.

Alere Paying $38.75 Million for False Claims Allegations

[ Price : $8.95]

The Justice Department says Alere and a subsidiary will pay $38.75 million to resolve False Claims Act allegations involving defec...