FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Experts Call for Overhaul of FDA Revolving Door Rules

[ Price : $8.95]

Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...

FDA Raises Approval Standards for CAR-T Cancer Therapies

[ Price : $8.95]

CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on...

Potential Redefinition of Enforcement Boundaries: Attorneys

[ Price : $8.95]

Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially invol...

CGMP Issues at Seaway Pharma

[ Price : $8.95]

FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract ma...

First Approval Under New Priority Voucher Program

[ Price : $8.95]

FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...

Petition Urges FDA to Overhaul Biosimilar Approval Rules

[ Price : $8.95]

A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval require...

FDA OKs 1st Cellular Therapy for Severe Aplastic Anemia

[ Price : $8.95]

FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.

FDA Delays Safety Review of Abortion Pill Mifepristone

[ Price : $8.95]

FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026...

BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug

[ Price : $8.95]

BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with ...

FDA Delays Decision on Agios Mitapivat sNDA for Thalassemia

[ Price : $8.95]

FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both t...