The FDA nod marks a step forward in precision oncology, linking molecular diagnostics more tightly to therapy selection for advanced prostate cancer
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
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months
Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
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