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FDA
What’s in a Name? Contentious Fight Over Biosimilars Coming to a Head
WSJ Pharmalot
Fri, 06/12/15 - 10:46 pm
biosimilars
FDA
generics
GlaxoSmithKline's new asthma drug gets a split vote from FDA advisers
Fierce Biotech
Fri, 06/12/15 - 10:50 am
GSK
asthma
advisory panels
FDA
mepolizumab
Why Is Amgen Rising And Regeneron Falling?
Barron's
Fri, 06/12/15 - 10:44 am
Amgen
Regeneron
Sanofi
Repatha
Praluent
FDA
advisory panels
PCSK9 inhibitors
FDA Mistakenly Widened the Market for a Rare Sleep Disorder Drug: Petition
WSJ Pharmalot
Thu, 06/11/15 - 12:02 pm
FDA
Hetlioz
non-24 hour disorder
FDA panel backs Amgen's cholesterol drug for high-risk patients
Yahoo/Reuters
Wed, 06/10/15 - 06:13 pm
FDA
Amgen
Repatha
advisory panels
PCSK9 inhibitors
Why Regeneron’s down on a positive FDA recommendation
CNBC
Wed, 06/10/15 - 02:36 pm
Regeneron
Sanofi
Praluent
FDA
advisory panels
PCSK9 inhibitors
You're free to speak, FDA tells Amarin in bid to deflate free-speech suit
Fierce Pharma
Wed, 06/10/15 - 11:04 am
FDA
Amarin
free speech
Vascepa
FDA finally responds to demand for Duchenne Muscular Dystrophy guidance
BioPharma Dive
Wed, 06/10/15 - 10:58 am
FDA
Duchenne Muscular Dystrophy
Saretpa
PTC Therapeutics
Pfizer
Biomarin
Advisory Panel Recommends Bluebird Delay Gene Therapy Clinical Trial
TheStreet.com
Wed, 06/10/15 - 09:04 am
Bluebird Bio
advisory panels
FDA
gene therapy
LentiGlobin
GSK asthma medication to go before FDA panel Thursday
Medical Marketing and Media
Tue, 06/9/15 - 11:47 pm
GSK
asthma
FDA
advisory panels
mepolizumab
Sanofi/Regeneron's PCSK9 blockbuster-in-waiting gets prelim FDA nod
BioPharma Dive
Tue, 06/9/15 - 06:33 pm
Sanofi
Regeneron
PCSK9 inhibitors
FDA
advisory panels
Praluent
FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info
WSJ Pharmalot
Tue, 06/9/15 - 02:01 pm
FDA
free speech
Amarin
FDA's High Bar For Breakthrough Therapy Designations
Seeking Alpha
Tue, 06/9/15 - 11:57 am
FDA
breakthrough therapies
PCSK9 adcomm preview: what's at stake
Medical Marketing and Media
Tue, 06/9/15 - 09:32 am
PCSK9 inhibitors
FDA
advisory panels
Sanofi
Regeneron
Amgen
Repatha
Praluent
Genmab shares rise on cancer drug's FDA license application
Yahoo/Reuters
Mon, 06/8/15 - 10:07 am
Genmab
FDA
JNJ
daratumumab
Multiple Myeloma
Amgen's Repatha lowers LDL, no marked safety events-FDA staff
Yahoo/Reuters
Mon, 06/8/15 - 10:06 am
Amgen
Repatha
FDA
LDL cholesterol
New Mega-Blockbuster Cholesterol Drug Class Faces Make-or-Break FDA Panels
24/7 Wall St
Sun, 06/7/15 - 10:57 am
FDA
advisory panels
Regeneron
AbbVie
Amgen
Repatha
alirocumab
PCSK9 inhibitors
The Fight Against Cholesterol Heats Up; FDA Panel Considers Drugs from Regeneron, Amgen Next Week
Barron's
Fri, 06/5/15 - 12:22 pm
FDA
advisory panels
Regeneron
Sanofi
Amgen
PCSK9 inhibitors
Praluent
FDA staff: Sanofi/Regeneron drug lowers LDL; is well tolerated
Yahoo/Reuters
Fri, 06/5/15 - 09:20 am
FDA
Sanofi
Regeneron
alirocumab
advisory panels
‘Viagra for Women’ is Recommended by an FDA Panel, With Some Caveats
WSJ Pharmalot
Thu, 06/4/15 - 08:10 pm
FDA
advisory panel
female sexual dysfunction
flibanserin
Sprout Pharmaceuticals
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