FDA

Positive PhIII leaves Neurocrine lining up for an FDA filing for tardive dyskinesia
Fierce Biotech
Thu, 10/8/15 - 09:32 am
Neurocrine
FDA
NBI-98854
tardive dyskinesia
Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer
Yahoo
Thu, 10/8/15 - 09:13 am
Eli Lilly
abemaciclib
advanced breast cancer
FDA
breakthrough therapies
The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews
Fierce Biotech
Thu, 10/8/15 - 09:09 am
FDA
priority review
review vouchers
UBS analysts weigh in on FDA’s expanded approval of Merck’s Keytruda for the treatment of lung cancer
Bidness, ETC
Wed, 10/7/15 - 10:05 am
Merck
non-small cell lung cancer
FDA
Keytruda
TransMedics wins FDA panel date for organ preservation device
Mass Device
Wed, 10/7/15 - 09:58 am
TransMedics
FDA
advisory panels
organ preservation
devices
Advaxis shares drop after FDA clinical trial hold
Marketwatch
Tue, 10/6/15 - 07:10 pm
Advaxis
FDA
clinical trials
axalimogene filolisbac
cervical cancer
Alkermes wins an FDA nod for its monthly schizophrenia drug
Fierce Biotech
Tue, 10/6/15 - 09:58 am
FDA
Alkermes
schizophrenia
Aristada
Abilify
Gilead Sciences Letairis Wins FDA Nod For PAH: Stock To Recover Soon
Bidness, ETC
Tue, 10/6/15 - 09:51 am
PAH
pulmonary arterial hypertension
FDA
Gilead Sciences
Letairis
2,000% Drug Price Surge Is a Side Effect of FDA Safety Program
Bloomberg
Tue, 10/6/15 - 08:15 am
Teva Pharmaceutical
Colcrys
FDA
gout
drug pricing
Avita jumps on FDA nod for expanded trial
Mass Device
Mon, 10/5/15 - 09:51 pm
Avita
FDA
clinical trials
devices
ReCell
wound care
Drug maker loses lawsuit filed to regain ‘lost’ marketing time
Pharmalot
Mon, 10/5/15 - 05:59 pm
Eisai
Fycompa
Belviq
FDA
DEA
market exclusivity
Otonomy heads to the clinic with a tinnitus drug
Fierce Biotech
Mon, 10/5/15 - 05:53 pm
Otonomy
tinnitus
FDA
OTO-311
St Jude gets FDA warning letter for Atlanta facility
Yahoo/Reuters
Sat, 10/3/15 - 02:24 pm
St. Jude Medical
devices
FDA
Atlanta
warnings
Merck's Keytruda snags FDA approval for NSCLC, but label is narrow
Fierce Pharma
Fri, 10/2/15 - 04:57 pm
Merck
Keytruda
FDA
non-small cell lung cancer
Amicus, Other Biotech CEOs Should Listen More, Talk Less About FDA Matters
TheStreet.com
Fri, 10/2/15 - 04:55 pm
Amicus Therapeutics
FDA
Chasing a ghost: Why is FDA guidance on biosim interchangeability taking so long?
BioPharma Dive
Fri, 10/2/15 - 11:40 am
FDA
biosimilars
On second thought, Amicus won't be filing its lead drug this year
Fierce Biotech
Fri, 10/2/15 - 10:45 am
Amicus
FDA
migalastat
Fabry's disease
FDA approves Bristol-Myers drug combination for skin cancer
Yahoo/Reuters
Thu, 10/1/15 - 09:22 am
FDA
Bristol-Myers Squibb
skin cancer
Opdivo
Yervoy
No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA
FDA Law Blog
Thu, 10/1/15 - 09:13 am
FDA
Eisai
exclusivity
Belviq
Fycompa
Omitting risk info in ads is top reason for FDA warning
Medical Marketing and Media
Wed, 09/30/15 - 07:54 pm
FDA
warnings

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