Shots:Chiesi Group has entered into an exclusive global collaboration & license deal with Arbor for ABO-101 in primary hyperoxaluria type 1 (PH1) & a multitarget option to use Arbor’s gene…
Shots: Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma In an exclusive conversation, Leonard Mazur, Co-Founder and…
Shots:The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapyProSense is a…
Shots:The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this yearAVT23 was jointly developed by Alvotech & Kashiv…
Shots:The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was…
Shots:Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm SuiteThe chronic kidney disease…
Shots:Health Canada has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy under priority reviewApproval was based on VISION-DMD study, which met its 1EP of…
Shots:Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the USIn Jan 2025, the FDA approved Avtozma…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below: Daiichi Sankyo & AstraZeneca…