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FDA
What to Call Biologic Copycats? FDA Proposes Names With Suffixes
Bloomberg
Thu, 08/27/15 - 10:05 am
drug names
biosimilars
FDA
Sarepta snags priority review status to keep pace with BioMarin in DMD race
Fierce Biotech
Wed, 08/26/15 - 09:28 am
Sarepta Therapeutics
priority review
Duchenne Muscular Dystrophy
FDA
eteplirsen
drisapersen
Biomarin
Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application
Forbes
Tue, 08/25/15 - 04:44 pm
FDA
drug approvals
FDA Grants Expanded Use of Promacta for Novartis
Yahoo/24-7 Wall St
Tue, 08/25/15 - 08:30 am
FDA
Novartis
Promacta
chronic immune thrombocytopenia
ITP
Epizyme Beats Out the Market With FDA Approval
Yahoo/24-7 Wall St
Mon, 08/24/15 - 05:00 pm
FDA
Epizyme
tazemetostat
INI1-negative tumors
synovial sarcoma
Sarepta, Biomarin vie for DMD approval, priority review voucher
BioPharma Dive
Mon, 08/24/15 - 11:47 am
Sarepta
Biomarin
Duchenne Muscular Dystrophy
FDA
priority review
review vouchers
FDA Grants Breakthrough Therapy Designation to Exelixis’ Cabozantinib for the Treatment of Renal Cell Carcinoma in Patients Who Received One Prior Therapy
Yahoo
Mon, 08/24/15 - 11:26 am
FDA
Exelixis
breakthrough therapies
renal cell carcinoma
cabozantinib
Why Four Months Is Worth $350m To AbbVie And Filgotinib
Seeking Alpha
Fri, 08/21/15 - 05:19 pm
AbbVie
filgotinib
FDA
review vouchers
priority review
Hunting an FDA cancer drug OK and a partner, little Telesta raises $28M
Fierce Biotech
Thu, 08/20/15 - 02:51 pm
FDA
Telesta
bladder cancer
The FDA Is Basically Approving Everything. Here's The Data To Prove It
Forbes
Thu, 08/20/15 - 09:08 am
FDA
drug approvals
FDA raises fees for medical device export certificates
Mass Device
Thu, 08/20/15 - 09:05 am
FDA
devices
exports
Corbus' shares soar on FDA news that could speed up drug approval
Bizjournals.com
Wed, 08/19/15 - 08:52 pm
Resunab
Corbus Pharmaceuticals
FDA
fast track
FDA Report Claims Improving RTA Rates, Reduced Medical Device Review Timeframes
Mass Device
Wed, 08/19/15 - 12:17 pm
FDA
devices
FDA Grants Qualified Infectious Disease Product (QIDP) Designation to VL-2397, Vical's Antifungal Product Candidate
Yahoo
Wed, 08/19/15 - 09:17 am
FDA
Vical
VL-2397
The FDA blundered badly on the Addyi approval
Fierce Biotech
Wed, 08/19/15 - 09:08 am
FDA
Addyi
female sexual dysfunction
drug approvals
Sprout Pharmaceuticals
Seattle Genetics drug wins FDA approval, could boost biotech's revenue
Bizjournals.com
Tue, 08/18/15 - 09:23 pm
FDA
Seattle Genetics
Adcetris
Hodgkin's lymphoma
FDA approves female sex pill, but with safety restrictions
Yahoo/AP
Tue, 08/18/15 - 09:21 pm
FDA
Sprout Pharmaceuticals
female sexual dysfunction
flibanserin
Addyi
Is Mylan's FDA Warning Letter Worth Worrying About?
Yahoo/Benzinga
Tue, 08/18/15 - 04:45 pm
Mylan Labs
FDA
warnings
Merck's Keytruda ready for quick FDA action on big melanoma expansion
Fierce Pharma
Tue, 08/18/15 - 01:36 pm
Merck
Keytruda
FDA
melanoma
Mylan, Critic of Indian Drugmakers, Warned by FDA on Quality
Bloomberg
Tue, 08/18/15 - 01:34 pm
India
FDA
Mylan Labs
generics
drug manufacturing
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