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FDA Accepts Amgen's Supplemental Biologics License Application to Expand Indication for Xgeva to Inc americanpharmaceuticalreview
June 22, 2017
Amgen announced the U.S. Food and Drug Administration (FDA) has accepted the Xgeva (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-rela
Victoza Receives Positive Vote from FDA Advisory Committee americanpharmaceuticalreview
June 22, 2017
Novo Nordisk announced the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has completed its meeting regarding the supplemental New Drug Application (sNDA) for ...
FDA approves Adamis’ cheaper rival to EpiPen pharmaphorum
June 19, 2017
Mylan is faced with a new rival to its allergic reaction shot, EpiPen (epinephrine), after the FDA approved a generic from San Diego’s Adamis Pharmaceuticals.
FDA approves BioMarin’s manufacturing facility in Cork, Ireland europeanpharmaceuticalreview
June 19, 2017
The FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance.
The Big Era for Investment of “RNAi Drugs” from the Perspective of Two Newly Approved Drugs by FDA en-cphi.cn
June 16, 2017
FDA approved the Exondys 51 (eteplirsen) of Sarepta Therapeutics on September 19, 2016 for treating exon 51 skipping Duchenne muscular dystrophy (DMD).
Thornhill Medical's Portable Emergency Life Support System receives 510K Clearance from the US FDA biospectrumasia
June 15, 2017
The MOVES SLC Portable Emergency Life Support System extracts oxygen from the air to deliver 85% FiO2 concentrations for ventilated patients, without the need for O2 tanks.
FDA Requests Removal of Opana ER for Risks Related To Abuse americanpharmaceuticalreview
June 12, 2017
The U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concer
FDA makes unprecedented move, asks Endo to pull painkiller from market pharmaphorum
June 12, 2017
The FDA has asked Endo to voluntarily remove its painkiller Opana ER from the US market, because of concerns it is fuelling the country’s opioid addiction epidemic.
SHP465 back in front of the FDA and data for Venclexta epvantage
June 12, 2017
SHP465 back in front of the FDA and data for Venclexta
FDA’s move could mean Endo suffers from opioid withdrawal epvantage
June 12, 2017
FDA’s move means that Endo suffers from opioid withdrawal

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