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news.Merck gets FDA priority review for Recarbrio in HABP/VABP
The supplemental New Drug Application (sNDA), which has been filed by the company and accepted by the regulator, is seeking approval for using Recarbrio for treating adult patients
The supplemental New Drug Application (sNDA), which has been filed by the company and accepted by the regulator, is seeking approval for using Recarbrio for treating adult patients
BAT1706 is being developed by Bio-Thera Solutions as a proposed biosimilar to Avastin. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients
Palforzia, which was formerly known as AR101, has been indicated in the US for the mitigation of anaphylaxis and other allergic reactions following accidental exposure to peanut. The
The application was originally filed in 2018 for patients with first-line NSCLC who have tumor mutational burden ≥10 mutations/megabase, based on the final analysis of progression-free survival, a
The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a
Pulmatrix is currently enrolling patients in its ongoing randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, pulmonary function and biomarker response of Pulmazole in subjects with
The APR-246, azacitidine combination has been granted breakthrough therapy status for the treatment of myelodysplastic syndromes in patients having a susceptible TP53 mutation. Myelodysplastic syndromes are defined as
NOSTRA III is a 220 patient Phase III clinical trial assessing efficacy and safety of Ronopternin (VAS203) for the treatment of moderately to severely injured closed head traumatic
As part of this work, the Company has initiated efforts to develop a vaccine candidate against 2019-nCoV and broadly collaborate with others to screen a library of antiviral
The company, through its new drug application (NDA), has been seeking FDA approval for selpercatinib for the treatment of advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET