News | June 26, 2025
Philogen withdraws marketing authorization application for Nidlegy in EU
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
Relonchem Limited has received Marketing Authorization for the product Levonorgestrel 1.5 mg Tablets from UK MHRA
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
These approvals mark significant progress for Venus Remedies in expanding its market presence
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Company intends to increase sales in the UK to approximately 2 million Euros by focusing on seven molecules which are already registered in the country
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