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FDA Grants Orphan Drug Designation to Boehringer Ingelheim's Investigational Anti-CD33 Monoclonal An americanpharmaceuticalreview
March 13, 2017
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS).
FDA accepts sNDA for Vraylar cphi-online
March 10, 2017
Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.
13 FDA observations on Dr Reddy's plant send shares to 3 year low pharmafile
March 10, 2017
Indian pharmaceutical firm Dr Reddy’s has seen its shares drop on the Bombay Stock Exchange to ...
FDA Grants Orphan Drug Designation to CSRA’s DynPort Vaccine Company for Plague Vaccine firstwordpharma
March 09, 2017
DynPort's clinical stage recombinant Yersinia pestis rF1V plague vaccine to benefit from FDA Orphan Drug Designation
FDA Accepts sBLA Filing of Soliris® as a Potential Treatment for Patients with Refractory Generalize americanpharmaceuticalreview
March 09, 2017
Alexion Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental Biologics License Application (sBLA) to extend the indication for Soliris® (eculizumab) as a potential treatment for
FDA and NICE approve of first new hyperparathyroidism drug in 12 years pharmafile
March 09, 2017
The FDA has given the go-ahead for Amgen’s hyperparathyroidism (HPT) therapy Parsabiv (etelcalcetide), marking the...
Teligent, Receives FDA Approval of Clobetasol Propionate Gel, 0.05% americanpharmaceuticalreview
March 09, 2017
Teligent, a New Jersey-based specialty generic pharmaceutical company, has received approval of the company's abbreviated new drug application (ANDA) from the U.S.
FDA Accepts Supplemental New Drug Application for Allergan’s VRAYLAR americanpharmaceuticalreview
March 09, 2017
Allergan has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating VRAYLAR for the maintena
FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory drugs.com
March 07, 2017
Celgene Corporation and Agios Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene's New Drug Application.
PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the drugs.com
March 07, 2017
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA)...

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