AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations
Posted on30 Sep 2020
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AbbVie announced that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an... 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
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
PaxVax’s chikungunya vaccine receives US FDA fast track designation
PaxVax, a leading independent specialty vaccine company, has received Fast Track designation from the US Food and Drug Administration (FDA) for its... 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
USFDA new drug approval: Xermelo for carcinoid syndrome diarrhea
Posted on03 Mar 2017
Tags2017 USFDA New Drug Apporval, Fast Track designation, orphan drug designation, priority review, Xermelo
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The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment... Read More
2017 USFDA New Drug Apporval: Emflaza tablets to treat Duchenne muscular dystrophy
The US Food and Drug Administration has approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older... Read More
USFDA approved first drug for spinal muscular atrophy
Posted on29 Dec 2016
TagsBiogen, Fast Track designation, Ionis Pharmaceuticals, Nusinersen, priority review, spinal muscular atrophy, Spinraza
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The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular... Read More
FDA grants accelerated approval to Eteplirsen, first drug for Duchenne muscular dystrophy
Posted on23 Sep 2016
TagsDuchenne muscular dystrophy, Eteplirsen, Fast Track designation, orphan drug, orphan drug designation, priority review
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The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular... Read More
FDA grants Fast Track status for MediciNova’s MN-001
Posted on14 Sep 2015
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MediciNova, Inc., a biopharmaceutical company, has received Fast Track designation from the US Food and Drug Administration (FDA) for MN-001 (tipelukast) for... Read More