FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Pharvaris Clinical Hold Lifted

[ Price : $8.95]

FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of ...

Draft Guide on Orthopedic Device Coatings

[ Price : $8.95]

FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices....

Priority Review for Xolair Food Allergy sBLA

[ Price : $8.95]

FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including an...

De Novo OK for Osteopenia Device

[ Price : $8.95]

FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-bas...

Gilead Trodelvy Trial Misses Endpoint

[ Price : $8.95]

Gilead Sciences says its Trodelvy Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival in previously treat...

Kallisio Oral Stent Cleared

[ Price : $8.95]

FDA clears a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patie...

Info Collection on Rx Drug Marketing

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Marketing: Administr...

Qulipta Approval Used Priority Voucher

[ Price : $8.95]

Federal Register notice: FDA announces that Abbvies Qulipta was approved using a material threat medical countermeasure priority r...

Panel to Vote on Abbott TriClip PMA

[ Price : $8.95]

Federal Register notice: FDA announces a 2/13 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel ...

Panel to Vote on Lumicell NDA

[ Price : $8.95]

Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA...