The FDA nod marks a step forward in precision oncology, linking molecular diagnostics more tightly to therapy selection for advanced prostate cancer
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms
The regulatory decision follows promising results from RIVER-81
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The move makes EBGLYSS the only therapy offering as few as six maintenance injections per year
Broadening access for children & patients with inhibitor-complicated hemophilia
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
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