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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Breakthrough Therapy Designation was created for drugs that may be significantly better treatments for serious diseases or conditions. [8] On November 13, 2013, the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche [9] for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation.
We look forward to continued collaboration with the FDA to bring an effective therapy to the Hunter syndrome community as soon as possible.” Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions.
CAMBRIDGE, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – Biogen announced today that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T ...
Designed as a way to bring potentially life-changing drugs to pharmacy shelves faster than ever, the Food and Drug Administration Safety and Innovation Act, which passed last year, came with a ...
The FDA grants Breakthrough Therapy designation to Bristol-Myers Squibb's (BMY) Orencia for the prevention of moderate-to-severe acute GvHD in hematopoietic SCT from unrelated donors.
Novartis's (NVS) crizanlizumab gets Breakthrough Therapy designation by the FDA for the prevention of VOCs in patients of all genotypes with SCD.