The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
Accomplished molecular microbiologist and protein engineer takes charge of CSIR-IMTECH after serving in key scientific and regulatory leadership roles at FSSAI
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
Deal expands SPI Pharma’s manufacturing footprint in Germany, enhances pharmaceutical ingredient offerings, and reinforces focus on fast-growing digestive health market
The results come from post-hoc analyses of more than 1,500 women enrolled in the Phase 3 ATTAIN-1 and ATTAIN-2 trials, presented at the American Diabetes Association’s 86th Scientific Sessions
Based on the cumulative data from ACHIEVE-1 through ACHIEVE-5, Lilly plans to submit orforglipron for FDA approval for the treatment of type 2 diabetes by the end of the second quarter
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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