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This designation applies when olomorasib is used in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the initial treatment of unresectable advanced or metastatic non-small cell lung cancer

According to the agreements, MS Pharma will oversee the registration, marketing along with the distribution of vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019) throughout MENA. Polpharma Biologics will

This round of financing was led by SV Health Investors’ Dementia Discovery Fund (DDF), with contributions from existing investors including Newpath Partners, OrbiMed, Euclidean Capital, Chugai Venture Fund,

This change eliminates the previous requirement for a cardiovascular disease diagnosis prior to treatment. Amgen global commercial operations executive vice president Murdo Gordon said: “Far too many adults

The investment equips NewAmsterdam Pharma with the commercial capability to produce a fixed dose combination (FDC) of obicetrapib and ezetimibe, thereby addressing potential market demand. Piramal Pharma Solutions

Brukinsa’s recommended dose remains 320mg a day. The new tablets, each 160mg, allow patients to halve their intake of daily pill from four to two. Moreover, these tablets

Additionally, this combination is approved for the treatment of unresectable or advanced hepatocellular carcinoma (HCC). The approval introduces a dual immunotherapy option for two difficult-to-treat gastrointestinal cancers. Evidence

This designation comes after the FDA Office of Orphan Products Development reviewed recent Phase IIa clinical trial results, which showed both biological efficacy and safety in patients with

The FDA’s designation is designed to expedite the review of treatments. It offers opportunities for more frequent discussions with the FDA regarding the clinical development plan of a