FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Moderna Wins Approval for mRNA Flu Vaccine

[ Price : $8.95]

FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.

FDA Signals Increased Scrutiny of Unapproved Animal-Derived Thyroid Drugs

[ Price : $8.95]

FDA signals that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which a...

Surge In FDA Drug Warning Letters Shows Structural Problem: Consultant

[ Price : $8.95]

Krieger Scientific founder Joseph Morwald says a surge in FDA drug Warning Letters is driven by an industry systemic problem that ...

AdvaMed Strongly Backs MDUFA 6 Agreement

[ Price : $8.95]

AdvaMed voices strong public support for the MDUFA 6 commitment reached with FDA.

FDA Accelerated Approval for Replimune Melanoma Therapy

[ Price : $8.95]

FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic vi...

Device Regulators Guide on Change Control Plans for Device Software

[ Price : $8.95]

The International Medical Device Regulators Forum releases a final document outlining global principles for Predetermined Change C...

Merck sBLA for Expanded Use of RSV Therapy

[ Price : $8.95]

FDA accepts for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing re...

FDA Launches DSCSA Small Dispenser Assessment

[ Price : $8.95]

FDA calls on small drug dispensers with no more than 25 employees to complete an assessment so the agency can evaluate the dispens...

Reps. Want FDA to Address Estrogen Patch Shortages

[ Price : $8.95]

Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of...

Senators Press FDA for Details on Addressing Chemotherapy Shortages

[ Price : $8.95]

Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs...