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Inotersen NDA Accepted for Priority Review by FDA americanpharmaceuticalreview
January 09, 2018
Ionis Pharmaceuticals announced its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA)
FDA grants fast-track designation to malaria drug Tafenoquine pharmaceutical-technology
January 09, 2018
The US Food and Drug Administration (FDA) has granted fast-track designation to 60 Degrees Pharmaceuticals’ (60P) Tafenoquine for the prevention of malaria in adults.
Orchid Pharma gets EIR from US FDA expressbpd
January 09, 2018
The Chennai facility was recently inspected by US FDA
Summary of M&As in 2017 Dopine
January 08, 2018
2018 is here. I’d like to summarize characteristics of the M&As in the pharmaceutical field of 2017.
The FDA Fast Tracks 60 Degrees Pharma's Malaria Drug biospace
January 05, 2018
60 Degrees Pharma Fast Tracked for Malaria Drug
FDA Bestows Breakthrough Tag on Shire's Maribavir biospace
January 05, 2018
Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients
Novartis Announces 2018's Second FDA Breakthrough Tag of the Week biospace
January 05, 2018
A Novartis drug approved as a second-line treatment for a blood disorder snagged the U.S. Food and Drug Administration’s Breakthrough Therapy Designation as a first-line defense.
Palatin Technologies Announces FDA Clearance of IND Application for PL-8177 for Ulcerative Colitis biospace
January 04, 2018
Palatin Technologies announced today that the U.S. Food and Drug Administration (FDA) may continue its subcutaneous injection of PL-8177 as a potential clinical study of patients with ulcerative colitis
FDA Hails Novartis' Kisqali a Breakthrough biospace
January 04, 2018
Little more than 10 months after its approval to treat some postmenopausal breast cancer patients, Novartis’ Kisqali (ribociclib) snagged Breakthrough Therapy Designation to treat a new segment of premenopausal breast cancer patients.
FDA approves shock wave wound healing device pharmafile
January 03, 2018
Continuing its recent trend to promote innovative new technologies, the FDA has announced that it has approved a medical device that uses shock waves to help promote wound healing in those suffering from diabetes.

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