A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.
An independent panel to the U.S. Food and Drug Administration voted in favor of approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
FDA Action Alert
Acromegaly, Blockbusters, Checkpoint Inhibitors, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Diffuse Large B-Cell Lymphoma (DLBCL), Dravet syndrome, FDA/Regulatory, NDA Resubmission, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Postoperative Pain, R&D, Seizures, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), TherapeuticsWrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Shares of Epizyme stock rose after the company’s first-in-class EZH2 inhibitor Tazverik won approval from the U.S. Food and Drug Administration for the second time in 2020.
Cambridge-based Magenta Therapeutics entered a non-exclusive research and clinical collaboration agreement with Beam Therapeutics.
FDA Action Alert
Atopic Dermatitis (Eczema), Auto-Injection Therapy, B Cells, Biologics License Application (BLA), Complicated Urinary Tract Infections (cUTI), Diabetic Gastroparesis, Eosinophilic Asthma, FDA, FDA/Regulatory, Follicular Lymphoma, Inflammatory Diseases, Monoclonal Antibodies, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Pediatric Asthma, Prescription Drug User-Fee Act (PDUFA), Priority Review Status, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA)A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The U.S. Food and Drug Administration extended the review period for Novartis AG’s multiple sclerosis drug ofatumumab by three months.
ASCO 2020 Highlights
American Society of Clinical Oncology (ASCO), Analysis, Androgen Deprivation Therapy (ADT), CAR-T Therapy, Clinical Data, Clinical Trials, Gastrointestinal Stromal Tumors, High-Risk Myelodysplastic Syndrome (MDS), Leukemia, Metastatic non-small cell lung cancer, Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC), PD-1/PD-L1 inhibitors, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, Triple Negative Breast Cancer (TNBC)The American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually this year due to the COVID-19 pandemic and included hundreds of abstracts, posters and presentations.
Swiss drugmakers Roche and Novartis underscored how their portfolios are increasingly clashing on the commercial battlefield, announcing new data on drugs aimed at capturing market share from each other.