Puma Biotechnology, Inc. announced that the FDA has accepted for review the New Drug Application (NDA) for its lead product...
Puma Biotechnology has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PB 272 (neratinib). The...
Vivus Inc. announced that it has entered into a License and Commercialization Agreement with Sanofi to commercialize avanafil on an...
PhaseBio Pharmaceuticals announced interim results from REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) ongoing pivotal Phase III trial of PB 2452 (bentracimab) studying the reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with urgent surgery or an invasive procedure or experiencing uncontrolled major or life-threatening bleeding.
The FDA has allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens...
Peripheral-blood (PB) and bone marrow (BM) are both widely used in hematopoietic stem cell transplantation (HSCT). However, it is unclear whether PB or BM produces a more satisfactory outcome in haploidentical HSCT...
Puma Biotechnology, Inc. announced top line results from the Phase II clinical trial of Puma's investigational drug PB 272 (neratinib)...
Amylyx Pharmaceuticals announced that the FDA has extended the review timeline of the New Drug Application (NDA) for AMX 0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).
Spinal muscular atrophy (SMA) is caused by insufficient levels of survival motor neuron (SMN) protein. Recently, we found that sodium 4-phenylbutyrate (PB), a well-tolerated FDA approved drug, enhances SMN gene expression in vitro.
Amylyx Pharmaceuticals announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AMX 0035 (sodium phenylbutyrate (PB) and ursodoxicoltaurine (TURSO; also known as taurursodiol)) for the treatment of amyotrophic lateral sclerosis (ALS).