Lysogene, a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).
Takeda Pharmaceutical has secured priority review for ALUNBRIG (brigatinib) from the US Food and Drug Administration (FDA) for its expanded use as a first-line treatment for a type of non-small cell lung cancer (NSCLC).
Eli Lilly and Company (Lilly) has been granted approval for Trulicity (dulaglutide) from the US Food and Drug Administration (FDA) for reducing the risk of major adverse cardiovascular events (MACE) in adults having type 2 diabetes.
Lundbeck, a Danish pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA) for its Vyepti as a preventive treatment for migraine in adult patients.
FORMA Therapeutics, a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, FT-4202, in development as a disease-modifying treatment for sickle cell disease (SCD). FT-4202 is a selective pyruvate kinase-R (PKR) activator that exhibits the potential to beneficially impact both anemia and vaso-occlusive crises for people living with SCD.
Genentech, a member of the Roche Group, said that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.
Seattle Genetics and Astellas Pharma have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for Padcev in combination with Merck’s anti-PD-1 therapy Keytruda to treat advanced bladder cancer.
Pfizer has secured European approval for its oral transthyretin stabilizer VYNDAQEL (tafamidis) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Merck said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding its supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.
ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.
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