Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as […]readmore
Tags : FDA
Shots: The US FDA has granted ODD to the Ketamine for the treatment of complex regional pain syndrome (CRPS) which is a rare chronic pain and inflammatory condition following an […]readmore
Shots: The US FDA has lifted the clinical hold on the rusfertide development program & allow to resume patient dosing in clinical studies of rusfertide The company provides the information […]readmore
Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & symptom onset within 5 days […]readmore
Shots: The designation is based on the data from an ongoing SCarlet RoAD, Marguerite RoAD OLE trials along with other studies evaluating gantenerumab (anti-amyloid beta Ab) in patients with AD, […]readmore
Shots: The company has submitted an sBLA to the US FDA for an expanded approval of Stelara (ustekinumab) to treat pediatric patients ≥aged 5yrs. with jPsA The submission is based […]readmore
Shots: The US FDA’s AMDAC voted to recommend the use of maribavir (TAK-620) to treat refractory CMV infection and disease with/out genotypic resistance to ganciclovir, valganciclovir, foscarnet, or cidofovir in […]readmore
Shots: The US FDA has placed a clinical hold on the ALPHA2 study that evaluates ALLO-501A CAR T in 100+ patients with large B-cell lymphoma The discontinuation is due to […]readmore
Shots: The approval is based on the P-III ADVOCATE trial that evaluates Tavneos in 330 patients with ANCA-associated vasculitis across 20 countries. Patients were randomized to receive either rituximab or […]readmore
Shots: The submission is based on the P-III ENSEMBLE 2 study that evaluates the booster dose COVID-19 vaccine in adults aged ≥18yrs with COVID-19 The results demonstrated a 94% protection […]readmore