FDA

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
FDA grants breathrough therapy designation to Genzyme's Olipudase Alfa
Yahoo/Reuters
Thu, 06/4/15 - 11:51 am
Genzyme
FDA
olipudase alfa
Sanofi
Niemann-Pick disease
Return of the Scarlet Letter? AbbVie Petitions FDA to Require Biosimilar Labeling to Include Disclaimers and a Description of Data Differences
Fierce Pharma Marketing
Wed, 06/3/15 - 07:40 pm
FDA
biosimilars
AbbVie
Lawmaker Targets FDA for Letters Sent to Drugmakers About Infractions
WSJ Pharmalot
Wed, 06/3/15 - 07:32 pm
FDA
warnings
FDA panel to discuss Lilly's lung cancer drug approval
Yahoo/Reuters
Tue, 06/2/15 - 04:57 pm
FDA
advisory panels
Eli Lilly
necitumumab
lung cancer
Concerns remain for 'Viagra for women' twice rejected by FDA
Yahoo/AP
Tue, 06/2/15 - 04:32 pm
female sexual dysfunction
flibanserin
FDA
Sprout Pharmaceuticals
Amgen preps an FDA pitch for its late-stage kidney drug
Fierce Biotech
Fri, 05/29/15 - 11:07 am
Amgen
FDA
AMG 416
Heron soars as twice-rejected nausea drug comes through in Phase III
Fierce Biotech
Fri, 05/29/15 - 10:51 am
Heron
chemotherapy-induced nausea and vomiting
FDA
FDA approves Pfizer drug to treat very rare lung disease
Yahoo/Reuters
Thu, 05/28/15 - 07:22 pm
FDA
Pfizer
Rapamune
LAM
Lymphangioleiomyomatosis
FDA asks dermal filler makers to indicate risk of serious injury
Yahoo/Reuters
Thu, 05/28/15 - 03:16 pm
FDA
dermal fillers
Allergan
Actavis
Valeant Pharmaceuticals
Otsuka loses lawsuit challenging FDA approval of generic Abilify
Yahoo/Reuters
Thu, 05/28/15 - 02:00 pm
Otsuka
FDA
Abilify
generics
Teva Pharmaceutical
FDA approves Actavis, Valeant drugs for irritable bowel syndrome
Yahoo/Reuters
Wed, 05/27/15 - 08:27 pm
FDA
Actavis
Valeant Pharmaceuticals
IBS
irritable bowel syndrome
Xifaxan
Viberzi
New bill seeks to spur FDA to form clearer social media rules
Medical Marketing and Media
Wed, 05/27/15 - 08:25 pm
FDA
social media
Retrophin Turns Asklepion Voucher Into $245M Sanofi Payday
Xconomy
Wed, 05/27/15 - 09:52 am
Retrophin
review vouchers
Sanofi
Asklepion Pharmaceuticals
FDA
Boehringer snags FDA approval for COPD combo drug
Fierce Biotech
Tue, 05/26/15 - 10:11 am
FDA
Boehringer Ingelheim
COPD
Stiolto Respimat
Spiriva
Striverdi
How to Fix the FDA: Carefully
Yahoo/Bloomberg
Fri, 05/22/15 - 11:09 am
FDA
Novartis' duo of COPD drugs clears Phase III on the path to an FDA decision
Fierce Biotech
Fri, 05/22/15 - 10:41 am
Novartis
COPD
FDA
NVA237
QVA149
Bristol-Myers Squibb Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatitis C Regimen
Yahoo
Wed, 05/20/15 - 10:20 am
Bristol-Myers Squibb
FDA
breakthrough therapies
daclatasvir
hepatitis C
sofosbuvir
FDA Tells Sarepta Therapeutics: Come on Down With Your DMD Drug!
TheStreet.com
Tue, 05/19/15 - 05:02 pm
Sarepta Therapeutics
FDA
Duchenne Muscular Dystrophy
eteplirsen

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