Protalix Announces FDA Investigational New Drug Clearance to Commence Once-Monthly Dosing Study of Pegunigalsidase Alfa (PRX-102) for the Treatment of Fabry Disease
CARMIEL, Israel, May 09, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug application (IND) for a clinical trial... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 9, 2017 Category: Pharmaceuticals Source Type: clinical trials

Tesaro Announces Submission of Investigational New Drug Application for Anti-LAG Antibody TSR-033 to the U.S. FDA
WALTHAM, Mass., May 01, 2017 (GLOBE NEWSWIRE) -- Tesaro, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the submission of an Investigational New Drug (IND) Application for TSR-033 to the U.S. Food and Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 1, 2017 Category: Pharmaceuticals Source Type: clinical trials

CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas
LOS ANGELES, April 19, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR) today announced the U.S. Food and Drug Administration (FDA) has reached an agreement with CytRx on preparations for a New Drug Application (NDA) submission for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 19, 2017 Category: Pharmaceuticals Source Type: clinical trials

Athenex Announces the US FDA Allowance of the Investigational New Drug Application of Oratopo, A Combination of HM30181A and Oral Topotecan For the Treatment of Advanced Cancer
Buffalo, NY and Hong Kong – March 28, 2017 -- Athenex, Inc., a global specialty oncology pharmaceutical company focused on the development and commercialization of next generation therapies for cancer diseases and supportive therapies, announced... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 28, 2017 Category: Pharmaceuticals Source Type: clinical trials

Innocoll Receives Refusal to File Letter from U.S. FDA for XaraColl (bupivacaine HCl collagen-matrix implants) New Drug Application
ATHLONE, Ireland, Dec. 29, 2016 (GLOBE NEWSWIRE) -- Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that it has received a Refusal to File letter from the United States Food and Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 29, 2016 Category: Pharmaceuticals Source Type: clinical trials

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis
Basel, November 14, 2016 - Novartis today announced that the US Food and Drug Administration (FDA) granted Priority Review to the PKC412 (midostaurin) new drug application (NDA) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 14, 2016 Category: Pharmaceuticals Source Type: clinical trials

Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer
Basel, November 1, 2016 - Novartis announced today that the US Food and Drug Administration (FDA) accepted the company ' s New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) as first-line treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 1, 2016 Category: Pharmaceuticals Source Type: clinical trials

Aclaris Therapeutics Submits Investigational New Drug Application for ATI-50001 to Treat Alopecia Universalis and Alopecia Totalis
MALVERN, Pa., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for its drug candidate... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 31, 2016 Category: Pharmaceuticals Source Type: clinical trials

Mallinckrodt Submits Investigational New Drug Application for Synacthen Depot
CHESTERFIELD, United Kingdom, June 13, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced it has submitted an Investigational New Drug (IND) application for Synacthen® Depot to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 13, 2016 Category: Pharmaceuticals Source Type: clinical trials

Theravance Biopharma Highlights Acceleration of Timeline for Filing U.S. New Drug Application for the Closed Triple by GlaxoSmithKline and Innoviva
DUBLIN, IRELAND -- (Marketwired) -- June 2, 2016 -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today announced that GlaxoSmithKline plc (GSK) and Innoviva, Inc. (Innoviva) have accelerated the timeline for filing a New Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 2, 2016 Category: Pharmaceuticals Source Type: clinical trials

Curis Announces FDA Acceptance of Investigational New Drug Application for CA-170, the First Orally Available Small Molecule to Target and Inhibit Immune Checkpoints
LEXINGTON, Mass., June 01, 2016 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 1, 2016 Category: Pharmaceuticals Source Type: clinical trials

Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma
CAMBRIDGE, Mass., May 4, 2016 --(BUSINESS WIRE)-- Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 4, 2016 Category: Pharmaceuticals Source Type: clinical trials