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news.SpringWorks gets EC orphan drug designation for NF1 treatment mirdametinib
Mirdametinib, formerly PD-0325901, is an oral and small molecule inhibitor of MEK1 and MEK2. The company has already secured orphan drug designation from the US Food and Drug
Mirdametinib, formerly PD-0325901, is an oral and small molecule inhibitor of MEK1 and MEK2. The company has already secured orphan drug designation from the US Food and Drug
Under an all-stock Reverse Morris Trust transaction, each share of Mylan will be converted into one share of the new company. The deal allows Pfizer shareholders to own
The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy. Deborah Waterhouse, CEO of ViiV
Epizyme has proposed an indication of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The FDA granted Priority Review for the NDA and has set
Under the deal, Zambon has made an upfront payment of €140m (£125m) to acquire Breath Therapeutics and its subsidiaries and the acquisition value could increase to €500m (£446m)
The part one of the phase 3 CheckMate -227 trial assessing Opdivo plus low-dose Yervoy (ipilimumab) achieved the co-primary endpoint of overall survival (OS). According to the company,
Upon completion of the merger, Gemphire will change its name to NeuroBo Pharmaceuticals, Inc., and plans to change its ticker symbol on the Nasdaq Capital Market to “NRBO.”
Ruxience, a monoclonal antibody (mAb), has been approved to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Ruxience works
The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega
The study aims to confirm that the biosimilar matches the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis. Denosumab is indicated