FDA has recently approved GSK’s triple therapy inhaler, the news follows on shortly from an EMA CHMP positive opinion and the FDA advisory panel’s recent nod for its shingles vaccine, Shingrix. The news was highly welcomed, especially in the chronic obstructive pulmonary disease (COPD) area, as the current major seller in the area, Advair, faces
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The Food and Drug Administration has approved Fast Track designation for Shire’s SHP607, a treatment used in the prevention of chronic lung disease in extremely premature infants. SHP607, which is currently in Phase 2 Clinical Development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its
Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in