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FDA approves Amgen's Repatha (evolocumab) biospectrumasia
December 08, 2017
In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization by 22 percent
FDA Approves OZEMPIC Injection for Type 2 Diabetes americanpharmaceuticalreview
December 07, 2017
Novo Nordisk announced theFDA approved its New Drug Application for OZEMPIC injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 di
FDA grants orphan drug status to Shire’s UC treatment SHP647 pharmaceutical-technology
December 04, 2017
FDA has granted orphan drug designation to Shire’s investigational mucosal addressin cell adhesion molecule-1 antibody, SHP647, for the treatment of paediatric patients with moderately to severely active ulcerative colitis
Zydus Pharmaceuticals (USA) receives US FDA approval expressbpd
December 04, 2017
Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US health regulator to market pregabalin capsules, used for the management of certain kinds of seizures, nerve pain and fibromyalgia.
First and only medicine of its kind for opioid use disorder approved by FDA pharmafile
December 04, 2017
FDA has announced the approvement of the first and only monthly buprenorphine injections which can now be used to treat moderate to severe opioid abuse
ECG Kardia Band becomes first-ever FDA-approved medical device accessory for Apple Watch pharmafile
December 01, 2017
The FDA has announced its approval of AliveCor’s Kardia Band, an electrocardiogram for use with the Apple Watch, marking the first authorisation of an accessory for the tech giant’s wearable as a medical device in the US.
FDA Announces New Approach to Advance Medicinal Nicotine Replacement Therapies as New Drugs americanpharmaceuticalreview
November 30, 2017
As the leading cause of preventable disease and death in the United States, tobacco causes more than 480,000 deaths every year.
FDA lifts second trial hold for Prescient’s lead drug, with one to go fiercebiotech
November 23, 2017
Slowly but surely, Australia’s Prescient Therapeutics is getting its lead cancer program back on track, with two of three trials subject to an FDA clinical hold now cleared to resume.
Janssen Submits Application to FDA to Expand Indication for DARZALEX americanpharmaceuticacreview
November 23, 2017
Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX (daratumumab).
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision with fda
November 23, 2017
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, which can make small adjustments to the implanted lens after cataract surgery.

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