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Opportunity or challenge? Favorable policies promote the increase of drug approval(1) en-cphi.cn
October 18, 2017
The U.S. Food and Drug Administration (FDA) is taking advantage of policy groundwork laid in past years to speed drug approvals.
FDA Approves STELARA for Adolescents with Moderate to Severe Plaque Psoriasis americanpharmaceuticacreview
October 17, 2017
Today's approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents.
AstraZeneca announces that Tagrisso granted breakthrough therapy designation (BTD) by US FDA pharmaasia
October 17, 2017
Tagrisso is a first-line treatment for EGFR mutation-positive non-small cell lung cancer. This is the sixth BTD for an AstraZeneca New Oncology medicine.
Philips receives U.S. FDA clearance to its solution for 'small parts' ultrasound imaging biospectrumasia
October 17, 2017
Industry first, one transducer solution and tailored clinical tools for 'small parts' ultrasound imaging, combined with power of Philips EPIQ and Affiniti, assesses diseases and disorders in one of the fastest growing segments of ultrasound exams.
NuVasive’s limb-lengthening tech earns expanded FDA clearance fiercebiotech
October 16, 2017
The FDA has expanded the clearance of NuVasive’s limb-lengthening system to include bone transport, a method that allows an orthopedic surgeon to regenerate bony tissue to fill a space where bone is missing.
Overview of NDA of FDA in Q3: Nearly Half of the 11 New Drugs Possessing “Blockbuster” Potential en-cphi.cn
October 13, 2017
FDA approved 11 new drugs in total (see the attached table for the details) in 2017 Q3. Time is the most objective judge and good things will always stand its tests.
Mylan and Biocon Neulasta biosimilar knocked back by FDA pharmafile
October 12, 2017
Mylan and Biocon’s biosimilar version of Amgen’s blockbuster, Neulasta (pegfilgrastim), will have to wait a bit longer before getting the nod from the FDA, after receiving a CRL related manufacturing plant issues
FDA Accepts sBLA for Prolia in Glucocorticoid-Induced Osteoporosis americanpharmaceuticacreview
October 11, 2017
Glucocorticoid medications, which are used to treat many inflammatory conditions, can cause significant side effects, including bone loss.
FDA approves multiple sclerosis drugs from Mylan, including first generic for Copaxone® pharmaasia
October 11, 2017
The FDA has approved several drugs from Mylan targeting multiple sclerosis, significantly including the first approved generic substitute for Copaxone®.
Lupin receives FDA approval for generic Corgard Tablets biospectrumasia
October 11, 2017
They are indicated for management of patients with angina pectoris and for the treatment of hypertension

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