US FDA grants Breakthrough Therapy Designation for Pfizer’s RSVpreF
Posted on25 Mar 2022
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Pfizer Inc. announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the US Food... Read More
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Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta earned this... Read More
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Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma
Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application... Read More
What are the major differences between – Breakthrough Therapy Designation Vs. Fast Track Designation Vs. Priority Review Designation Vs. Accelerated Approval
There is differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval. Here is a quick comparison of... Read More
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Kite Pharma’s axicabtagene got US FDA priority review status to treat NHL
Kite Pharma a leading cell therapy company, has announced that the US Food and Drug Administration (FDA) has accepted for priority review... Read More
USFDA granted Breakthrough Therapy Designation for Ignyta’s Entrectinib
Ignyta, Inc.,a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted... Read More