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Nov
23
ragupathyrenganathan
Strides Shasun gets USFDA nod to sell copycats of GSK’s Avodart
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Nov
20
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Merck and Pfizer receive FDA Breakthrough Therapy designation for avelumab in metastatic Merkel cell carcinoma
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Nov
18
ragupathyrenganathan
US FDA accepts Bristol-Myers Squibb’s sBLA for Opdivo in patients with advanced RCC
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Nov
17
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US FDA approves AstraZeneca’s Tagrisso to treat patients with EGFR T790M mutation-positive metastatic NSCLC
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Nov
13
ragupathyrenganathan
Is US drugs regulator shifting its focus to APIs and injectables?
Regulatory Affairs
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Nov
3
ragupathyrenganathan
Sun Pharma hit by US FDA ban on Gujarat plant
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Nov
3
ragupathyrenganathan
US FDA grants expanded indication to Integra LifeSciences’ CUSA Excel+ system for liver surgery
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Oct
19
ragupathyrenganathan
SonaCare gets US FDA marketing nod for its Sonablate HIFU prostate ablation device
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Jul
22
ragupathyrenganathan
US FDA approves Abbott’s iDesign Advanced WaveScan Studio System for use in LASIK procedures
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Jul
22
ragupathyrenganathan
Motif’s lead antobiotic candidate Iclaprim received US FDA QIDP designation
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