Drug Approval | July 30, 2024
Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment
The HALO AP platform was developed by Indica Labs to address the specific needs of anatomic pathology labs by supporting a wide range of tissue-based workflows, including primary diagnosis, secondary consults, tumour boards, clinical trials, synoptic reporting, quantitative analytics, and AI
The platform’s technology works as a compression algorithm for molecular testing
The company plans to expand its portfolio in regulated markets aggressively
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
The centralized marketing authorization granted by the EC is valid in all EU Member
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