usfda accelerated approval Archives • NCK Pharma

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...

BMS Opdivo+Yervoy combo received USFDA new indication approval.

Posted on15 Jul 2018

TagsAccelerated Approval, ipilimumab, nivolumab, Opdivo, usfda accelerated approval, Yervoy

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Bristol-Myers Squibb Company announced that its Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) has received...

Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval

What are the major differences between – Breakthrough Therapy Designation Vs. Fast Track Designation Vs. Priority Review Designation Vs. Accelerated Approval

Posted on24 Sep 2017

TagsAccelerated Approval, Breakthrough Therapy designation, Fast Track designation, FDA grants Priority Review for potential new indication for Brilinta, priority review, Priority Review Designation, usfda accelerated approval

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There is differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval. Here is a quick comparison of...

USFDA approved new drug Rubraca, rucaparib

Posted on21 Dec 2016

TagsBreakthrough Therapy designation, FDA grants breakthrough therapy designation, orphan drug, orphan drug act, orphan drug designation, surrogate endpoint, usfda accelerated approval

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The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian...

What is USFDA Accelerated Approval Program of new molecular entities?

Posted on30 May 2016

TagsOCALIVA, surrogate endpoint, usfda accelerated approval, What is surrogate endpoint?

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The FDA devised the Accelerated Approval Program to allow earlier approval of drugs that treat serious conditions, and that fill an unmet...

USFDA Accelerated Approval of OCALIVA

Posted on30 May 2016

TagsNew Drug, obeticholic acid, OCALIVA, usfda accelerated approval

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Molecule: obeticholic acid Brand Name: Ocaliva Type of Approval: New Drug Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization...