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Mar 31, 2025
Korea Medical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab)…
Mar 31, 2025
On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows…
Mar 28, 2025
On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment…
Mar 28, 2025
On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11…
Mar 27, 2025
On 27 March 2025, Roche’s subcutaneous Ocrevus® (ocrelizumab) was listed on the Australian Register of Therapeutic Goods (ARTG). This adds to the intravenous formulation of Ocrevus® listed on the ARTG in July 2017…
Mar 27, 2025
On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare…
Mar 27, 2025
At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions…
Mar 27, 2025
On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s…
Mar 27, 2025
On 27 March 2025, MSD announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab…
Mar 27, 2025
At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars…
Mar 27, 2025
On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program. Steqeyma® will be…
Mar 26, 2025
On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23…
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