Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma
SANTA MONICA, Calif.--(BUSINESS WIRE) August 8, 2017 -- Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 8, 2017 Category: Pharmaceuticals Source Type: clinical trials

Shire submits investigational New Drug Application to FDA for Gene Therapy candidate SHP654 for treatment of Hemophilia A
Lexington, Mass. – July 6, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, today announced the submission of an investigational new drug (IND) application to the U.S.... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 6, 2017 Category: Pharmaceuticals Source Type: clinical trials

Benznidazole IND for Chagas Disease Receives Clearance by FDA
BRISBANE, Calif., June 27, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today announced its Investigational New Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 27, 2017 Category: Pharmaceuticals Source Type: clinical trials

Loxo Oncology Announces FDA Clearance of Investigational New Drug (IND) Application for Next-Generation TRK Inhibitor, LOXO-195
STAMFORD, Conn., May 30, 2017 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the United... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 30, 2017 Category: Pharmaceuticals Source Type: clinical trials

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

FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer
TUCSON, Ariz.--(BUSINESS WIRE)-- April 13, 2017 Nuvox Pharma announces that the FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 13, 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

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

FDA Approves Investigational New Drug (IND) Application for Cantrixil (TRX-E-002-1) in Ovarian Cancer
SYDNEY, Sept. 12, 2016 /PRNewswire/ -- Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 12, 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

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