US FDA grants Priority Review to Mobocertinib of Takeda
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted priority ...
Read more
Tag: fda
FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ...
Read more
Amgen’s Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation
Amgen announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational ...
Read more
Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental NDA for Xywav™ Oral Solution
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has granted Priority ...
Read more
FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma
The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat ...
Read more
Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets and is eligible for 180 days of CGT exclusivity
Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration ...
Read more
U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has ...
Read more
FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based ...
Read more