US FDA grants priority review status to Sanofi’s BLA for avalglucosidase alfa to treat Pompe disease
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term... Read More
Insight on Veklury’s clinical and strategic pathway for USFDA approval for Covid-19
Posted on24 Oct 2020
TagsCOVID-19, priority review, Priority Review Designation, Remdesivir, usfda, usfda accelerated approval, USFDA Priority Review, Veklury
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USFDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at... Read More
CUTX-101 of Fortress Biotech gets US FDA rare pediatric disease designation to treat Menkes disease
Fortress Biotech, an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, announced that... Read More
Insighht on USFDA approval of Trikafta
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
Turalio: USFDA approval of first therapy for rare joint tumor
U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell... Read More
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Posted on17 Jul 2019
Tagscrizanlizumab, MAB, monoclonal antibody, priority review, Priority Review Designation, USFDA Priority Review
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Novartis announced the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) and has granted Priority Review for... Read More
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused... Read More
Quick look into Roche’s Tecentriq US FDA priority review grant
USFDA has accepted the Roche’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq. (atezolizumab), in combination with Avastin (bevacizumab),... Read More
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