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FDA
FDA alleges deleted files, hidden data at India's Wockhardt
BioPharma Dive
Sun, 01/31/16 - 01:35 pm
FDA
India
Wockhardt
Why the FDA shouldn’t bow to parental pressure over Duchenne drug
Stat
Tue, 01/26/16 - 09:17 pm
FDA
Duchenne Muscular Dystrophy
drug approvals
Biomarin
Sarepta Therapeutics
Amgen's Humira biosim is one step closer to FDA approval. But how close is it to market?
Fierce Pharma
Tue, 01/26/16 - 09:01 pm
Amgen
biosimilars
Humira
FDA
AbbVie
BMS' Opdivo evens the score in melanoma with two new FDA green lights
Fierce Pharma
Mon, 01/25/16 - 10:32 pm
Bristol-Myers Squibb
Opdivo
FDA
melanoma
FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
Yahoo
Mon, 01/25/16 - 10:22 pm
FDA
Amgen
biosimilars
biologics
ABP 501
Humira
Aratana Therapeutics Files for First FDA Approval
Yahoo
Mon, 01/25/16 - 10:02 pm
Aratana
FDA
animal health
FDA slaps Pfizer's Hospira unit for 'misleading' YouTube ad
Fierce Pharma
Fri, 01/22/16 - 09:04 am
FDA
Pfizer
OPDP
Hospira
YouTube
drug ads
Levaquin users slap J&J with $800M RICO suit, claiming pharma giant hid serious side effects
Fierce Pharma
Fri, 01/22/16 - 09:01 am
Levaquin
JNJ
RICO
antibiotics
FDA
FDA bans products from China plant used by Big Pharma players
Fierce Pharma Manufacturing
Thu, 01/21/16 - 07:51 pm
FDA
China
Zhejiang Hisoar
drug manufacturing
FDA gives full approval to Amgen blood cancer drug
Yahoo/Reuters
Thu, 01/21/16 - 06:18 pm
FDA
Amgen
Kyprolis
blood cancer
Zafgen Surges as New Drug Findings May Help Restart FDA Review
Bloomberg
Thu, 01/21/16 - 09:40 am
Zafgen
FDA
beloranib
FDA Postpones Advisory Committee Meeting to Review Eteplirsen Due to Severe Weather Storm in the Washington D.C. Area
Yahoo
Thu, 01/21/16 - 09:38 am
FDA
advisory panels
Duchenne Muscular Dystrophy
eteplirsen
Sarepta Therapeutics
Four big problems with the FDA’s analysis of Sarepta’s Duchenne drug data
Bizjournals.com
Wed, 01/20/16 - 09:31 pm
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
eteplirsen
Eisai scores FDA priority review for bigger Lenvima use in kidney cancer
Fierce Pharma
Wed, 01/20/16 - 08:40 am
Eisai
Lenvima
kidney cancer
FDA
priority review
Progress and collaboration on clinical trials
Mass Device
Tue, 01/19/16 - 08:13 am
FDA
CDER
clinical trials
FDA Grants Rare Pediatric Disease Designation to MediciNova’s MN-166 (ibudilast) for the Treatment of Krabbe Disease
Yahoo
Mon, 01/18/16 - 08:24 pm
FDA
MediciNova
MN-166
Faster U.S. Drug Approvals Come at Expense of Safety Oversight
Bloomberg
Mon, 01/18/16 - 12:55 pm
drug approvals
FDA
drug safety
FDA delays decision on Heron's twice-rejected nausea drug
Fierce Biotech
Sat, 01/16/16 - 11:25 am
FDA
Heron Therapeutics
Sustol
chemotherapy-induced nausea and vomiting
Preventing superbugs: FDA clears redesigned Olympus endoscope
Mass Device
Sat, 01/16/16 - 11:23 am
FDA
superbugs
devices
Olympus
endoscopes
duodenoscopes
Duchenne mom: FDA is ‘looking for reasons to deny’ Sarepta’s drug
Bizjournals.com
Fri, 01/15/16 - 02:28 pm
FDA
Sarepta Therapeutics
eteplirsen
Duchenne Muscular Dystrophy
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