USFDA

- Read more about Nivolumab with Ipilimumab regimen receives expanded FDA approval
U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Read more about XTL Biopharmaceuticals announces Encouraging Feedback from U.S. FDA on its upcoming IND filing for Lupus Drug
XTL Biopharmaceuticals, a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, announced the Company has received written guidance from the U.S. Food and Drug Administration (FDA) in response to a pre-investigational new drug (IND) meeting package regarding its upcoming IND filing for its drug candidate, hCDR1. Based on the FDA's response, XTL plans to file its IND, and in the coming quarters initiate a global clinical trial for hCDR1 in the treatment of systemic lupus erythematosus (SLE) in the U.S., Europe and Israel.
- Read more about Agenus announces clearance of IND applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies
Agenus Inc., an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, announced that the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was also received for a second CPM antibody partnered with Incyte (NASDAQ: INCY) for INCAGN1876, which targets glucocorticoid-induced TNFR-related protein (GITR). Clinical trials for both candidates are expected to begin in the first half of 2016.
- Read more about Pelvalon receives FDA clearance of Second-Generation non-Surgical Therapy for women suffering from loss of Bowel control
Pelvalon, a medical device company dedicated to developing innovative solutions for women suffering from loss of bowel control, today announced limited U.S. commercial availability of its Eclipse™ System, following U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s next-generation device.

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- Read more about Cellceutix gain FDA Orphan Drug Designation for Kevetrin
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that we received the letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer. The work underscoring the new designation was conducted by Cellceutix scientists in collaboration with pancreatic cancer specialists at a world filed grant application.
- Read more about Collegium Announces FDA acceptance of IND application for Abuse-Deterrent, Hydrocodone DETERx®
Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin a clinical trial of Hydrocodone DETERx®, an abuse-deterrent, extended-release analgesic for the treatment of chronic pain. This proof of concept clinical trial is intended to evaluate the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx.
- Read more about FDA Approves NEW Kyprolis® (Carfilzomib) COMBINATION THERAPY for the treatment of patients with Relapsed Or Refractory multiple myeloma
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.
- Read more about U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen®
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.
- Read more about AbbVie's Venetoclax receives breakthrough therapy designation from FDA in combination with Rituximab
AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.
- Read more about CymaBay Therapeutics announces successful completion of End-of-Phase 2 discussions with FDA for Arhalofenate
CymaBay Therapeutics, Inc, a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, announced that it has successfully concluded its end-of-phase 2 meeting discussions with the U.S. Food and Drug Administration (FDA) on the Phase 3 development program for arhalofenate.