FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Authorizes Colorado Prescription Drug Importation Program

[ Price : $8.95]

FDA authorizes Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug ...

FDA, MHRA Launch Liaison Program for Regulatory Cooperation

[ Price : $8.95]

FDA and the UK's Medicines and Healthcare products Regulatory Agency announce a new liaison program designed to strengthen collabo...

Jazz Trial Misses Survival Endpoint for Zepzelca in Lung Cancer

[ Price : $8.95]

Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed t...

AstraZeneca's Truqap for Prostate Cancer Approved

[ Price : $8.95]

FDA approves AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN...

Draft Guidance Clarifies Orange Book Patent Submission Forms

[ Price : $8.95]

FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Boo...

Welireg-Keytruda Combo OKd as Adjuvant Kidney Cancer Therapy

[ Price : $8.95]

FDA approves Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patien...

Amgen Outlines Basis for Hearing in Tavneos Withdrawal Effort

[ Price : $8.95]

A just-posted notice from Amgen outlines the basis for the company's defense of why its ANCA-associated vasculitis drug Tavneos sh...

17 Senate Democrats Hit HHS on FDA, Other Changes

[ Price : $8.95]

Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing ...

Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

[ Price : $8.95]

Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Bristol Myers Squibbs Sotyktu in a ...

CGMP Violations Seen in Port Jervis Records Review

[ Price : $8.95]

FDA cautions Port Jervis Laboratories in Port Jervis, NY, about CGMP violations in its manufacturing of over-the-counter drugs.