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About 800 results for "pdufa"

PDUFA date for Sarepta's eteplirsen now set for May 2608-02-2016

Shares of US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) were down 12.2.% at $10.74 in late-morning trading, after the company revealed it is facing yet another delay in a decision from the US Food and Drug Administration as to ... Pharma Letter, 4 days ago

Exelixis' cabozantinib NDA for advanced kidney cancer gets Priority Review; PDUFA date June 22

The FDA grants Priority Review status for Exelixis' ( EXEL -2.7%) New Drug Application (NDA) seeking clearance for Breakthrough Therapy- and Fast Track-tagged cabozantinib for the treatment of advanced renal cell carcinoma. Priority Review ...
 Seeking Alpha2 weeks ago FDA Grants Priority Review to KemPharm for KP201/APAP NDA  BioSpace3 days ago KEMPHARM : FDA Grants Priority Review to KemPharm for KP201/APAP NDA  4 Traders2 days ago Raptor Pharma's Procysbi receives fifth US patent  PharmaBiz2 weeks ago

Adam Feurestein Reminds Twitter Followers 'Today Is Merck's HepC elbasvir/grazoprevir PDUFA'

The Street's biotechnology and drug stock expert, Adam Feuerstein, reminded his Twitter followers of an important event with the healthcare space. Reminder: Today is $MRK HepC elbasvir/grazoprevir PDUFA. Co. spox knows first and most important ...
 Benzinga.com2 weeks ago

FDA action date tomorrow for review of Neos Therapeutics' NDA for ADHD candidate

Tomorrow is the FDA's PDUFA date for its review of Neos Therapeutics' ( NEOS -5%) New Drug Application (NDA) seeking clearance of NT-0202, an amphetamine extended-release orally disintegrating tablet, for the treatment of attention deficit ...
 Seeking Alpha2 weeks ago FDA extends action date for review of Sarepta's eteplirsen NDA to May 26  Seeking Alpha5 days ago

Heron Is A Buy On Likely Sustol Approval

When investing in pharmaceutical stocks, there are few times more exciting than a PDUFA date. This date can represent the culmination of years of Research and Development expenses for a company. For shareholders it is a pivotal moment where they can ...
 Seeking Alpha2 weeks ago FDA Delays PDUFA Date for Heron's Chemo Treatment  FDA News3 weeks ago Heron Therapeutics Notified by FDA That It Will Not Take Action on Sustol New Drug Application by the PDUFA Date  Drugs.com3 weeks ago HERON THERAPEUTICS : Notified by FDA That It Will Not Take Action on SUSTOLĀ® New Drug Application by the PDUFA Date  4 Traders4 weeks ago

FDA action date approaches for Merck's HCV single tablet combo

The FDA's PDUFA date for its Priority Review of Merck's ( MRK +1.1%) once-daily, single-tablet combination therapy, grazoprevir/elbasvir (100 mg/50mg), for the treatment of chronic hepatitis C infection (HCV) genotypes 1,4 or 6 is Thursday. The ...
 Seeking Alpha2 weeks ago

FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFA date November 16

The FDA accepts for review the Biologics License Application (BLA) submitted by AstraZeneca ( AZN +0.8%), in partnership with Valeant Pharmaceuticals ( VRX -0.5%), seeking clearance of brodalumab for the treatment of moderate-to-severe plaque ...
 Seeking Alpha2 weeks ago US FDA Accepts Green Cross' Biologics License Application for IVIG-SN  Sys-Con Media2 weeks ago GREEN CROSS : US FDA Accepts Green Cross' Biologics License Application for IVIG-SN  4 Traders1 week ago Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis  Equities.com1 week ago

Shire gets new PDUFA date for eye drug hopeful once spurned by FDA

Dive Brief: Shire has received a new PDUFA datefor its dry eye drug lifitegrastafter the FDA accepted its resubmitted new drug application (NDA). The FDA assigned the drug asix-month review period, setting anaction dateofJuly 22, 2016. The FDA in ...
 BioPharma Dive3 days ago FDA to decide on Shire blockbuster hopeful  Pharmafile5 days ago FDA action date for Shire's lifitegrast refiled NDA July 22  Seeking Alpha1 week ago Shire resubmits NDA for lifitegrast in response to FDA request for data  Orthopedics Today2 weeks ago

Last Week's Best Healthcare ETF

Image by PublicDomainPictures via Pixabay. It was another volatile week for the stock market, as the S&P 500 once again ended in the red. Investors continued to flee from the healthcare sector, too, as almost every single ETF that focuses on the ...
 Nasdaq6 hours ago
Motley Fool

3 Upcoming FDA Decisions We're Most Excited About

Photo source: . Interested in what biotechs might soon bag an important new drug approval? Then the Motley Fool has a treat for you today. Below, three of our contributors share their picks for biotechs on the cusp of a ...
 Motley Fool14 hours ago
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