VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Roche also shared the design of its upcoming Phase III TRONTIER 1 and 2 trials investigating trontinemab in people with early symptomatic Alzheimer’s disease
The company received one observation in the Form-483
The company is addressing these observations comprehensively
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
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