New Drug Application News and Research

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Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Mylan announces launch of generic Namenda Tablets in U.S.

Mylan announces launch of generic Namenda Tablets in U.S.

Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

FDA accepts BiondVax's IND for Multimeric-001 vaccine

FDA accepts BiondVax's IND for Multimeric-001 vaccine

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Trabectedin may be better than dacarbazine for treatment of soft tissue sarcoma

Trabectedin may be better than dacarbazine for treatment of soft tissue sarcoma

Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

PharmaEngine files NDA with Taiwan FDA for MM-398 to treat post-gemcitabine metastatic pancreatic cancer

PharmaEngine files NDA with Taiwan FDA for MM-398 to treat post-gemcitabine metastatic pancreatic cancer

Positive results from pacritinib Phase 3 trial for treatment of myelofibrosis presented at ASCO 2015

Positive results from pacritinib Phase 3 trial for treatment of myelofibrosis presented at ASCO 2015

ESSA Pharma reports net loss of $5.9 million for second quarter 2015

ESSA Pharma reports net loss of $5.9 million for second quarter 2015

Mast Therapeutics initiates Phase 3 extension study of vepoloxamer in sickle cell disease

Mast Therapeutics initiates Phase 3 extension study of vepoloxamer in sickle cell disease

FDA accepts Tris Pharma's Dyanavel XR NDA for review

FDA accepts Tris Pharma's Dyanavel XR NDA for review

Johns Hopkins researchers identify new therapy to treat lung cancer

Johns Hopkins researchers identify new therapy to treat lung cancer