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FDA
Otonomy wins FDA approval for a first-of-its-kind ear treatment
Fierce Biotech
Fri, 12/11/15 - 09:51 am
Otonomy
FDA
ear infections
Otiprio
The Ever-Expanding Biosimilar Labeling Debate – Institutional Investors Offer their Opinion and Request FDA to Hold a Hearing
FDA Law Blog
Fri, 12/11/15 - 09:40 am
FDA
biosimilars
Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer
Yahoo
Thu, 12/10/15 - 11:20 am
Pfizer
FDA
Ibrance
priority review
metastatic breast cancer
FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab
Yahoo
Thu, 12/10/15 - 11:18 am
Teva Pharmaceutical
FDA
advisory panels
reslizumab
asthma
Boston Scientific recalls Chariot sheaths; FDA labels it Class I
Mass Device
Thu, 12/10/15 - 11:11 am
Boston Scientific
Chariot sheaths
FDA
recalls
devices
FDA explains why it approved Addyi female sex pill
Stat
Wed, 12/9/15 - 09:35 pm
FDA
Addyi
female sexual dysfunction
Sprout Pharmaceuticals
J&J blood thinner under review for trial overseen by FDA nominee Califf
Stat
Wed, 12/9/15 - 11:44 am
JNJ
blood thinners
FDA
Xarelto
Robert Califf
FDA would shoot past 2014's new drugs record with just one more approval
BioPharma Dive
Wed, 12/9/15 - 11:41 am
FDA
drug approvals
U.S. drug approvals hit record level as biotech stocks sag
Bizjournals.com
Tue, 12/8/15 - 10:42 pm
FDA
drug approvals
biotech
[video]Top FDA Drug Approvals in 2015: Lung Cancer
Motley Fool
Tue, 12/8/15 - 10:41 pm
FDA
lung cancer
AstraZeneca
Tagrisso
Pfizer Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for XALKORI® (crizotinib) for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer
Yahoo
Tue, 12/8/15 - 11:24 am
Pfizer
FDA
Xalkori
non-small cell lung cancer
FDA approves Alexion Pharma's enzyme-replacement therapy
Yahoo/Reuters
Tue, 12/8/15 - 11:23 am
FDA
Alexion
Kanuma
Lysosomal Acid Lipase deficiency
FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Lower-Risk Myelodysplastic Syndromes
Yahoo
Mon, 12/7/15 - 10:34 am
FDA
fast track
luspatercept
myelodysplastic syndromes
FDA OKs first generic for Gleevec leukemia pill
Yahoo/AP
Fri, 12/4/15 - 08:25 pm
FDA
Gleevec
generics
Novartis
chronic myeloid leukemia
Sun Pharma
FDA delays proposed rule on safety warnings for generic drugs again
Stat
Fri, 12/4/15 - 08:23 pm
FDA
generics
In a Rare Move, FDA Initiates Procedures to Suspend Approval of an ANDA
FDA Law Blog
Fri, 12/4/15 - 08:21 pm
FDA
ANDAs
Armenpharm
FDA orders Zafgen to halt clinical trial for obesity drug
Boston Globe, MA
Thu, 12/3/15 - 09:51 pm
FDA
obesity
clinical trials
Zafgen
beloranib
Teva’s Phase III Clinical Trial: Reslizumab Helps Lung Function
Yahoo/Market Realist
Wed, 12/2/15 - 05:49 pm
FDA
Teva Pharmaceuticals
reslizumab
asthma
FDA to Repros: Wipe your PhIII drawing board clean and start over
Fierce Biotech
Wed, 12/2/15 - 09:34 am
FDA
Repros Therapeutics
enclomiphene
Androxal
low testosterone
Sarepta Therapeutics' Eteplirsen Likely To Get A Conditional Approval By FDA
Seeking Alpha
Tue, 12/1/15 - 08:54 pm
FDA
Duchenne Muscular Dystrophy
Sarepta Therapeutics
eteplirsen
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