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Amgen NDA for Etelcalcetide Accepted for Review

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FDA accepts for review an Amgen NDA for etelcalcetide (formerly AMG 416) for treating secondary hyperparathyroidism in patients wi...

FDA Panel Recommends Stricter Labeling for Fluoroquinolones

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FDAs Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommend a revised indicat...

Dr. Reddys Hit With Warning Letter Over India Facilities

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Dr. Reddys Laboratories joins the growing list of India-based companies coming under intense scrutiny by FDA after receiving a War...

Make Generics Look Like Brand Name Drugs: OGD

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CDER urges generic drug makers to make their generic copies look as much like the brand drug to help with patient compliance.

CDRH Accredits 3 UDI Issuing Agencies

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CDRH accredits three organizations as Unique Device Identifier (UDI) issuing agencies GS1, Health Industry Business Communication...

FDA Safety Review Positive for BMS Plavix

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An FDA safety review determines that long-term use of Bristol-Myers Squibbs blood-thinning drug Plavix (clopidogrel) does not incr...

FDA OKs TaiwanJ IND for Phase 2 Hepatitis Trial

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FDA approves a TaiwanJ Pharmaceuticals IND application for a Phase 2 clinical trial in patients with autoimmune hepatitis intolera...

CBER Says Some Pinnacle HCT/Ps are Drugs

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CBER says that some Pinnacle Transplant Technologies amniotic-based products are considered drugs and must have an approved BLA or...

Hamilton Medical Class 1 Recall of Ventilators

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Hamilton Medical begins a Class 1 recall of its Hamilton-G5 ventilator due to the potential for ventilation and alarms being suppr...

FDA Approves Glaxos Nucala for Asthma

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FDA approves a GlaxoSmithKline NDA for Nucala (mepolizumab) for use with other asthma medicines as maintenance treatment in patien...