Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% and 0.06% are bioequivalent to Atrovent Nasal Spray, 0.03% and 0.06%, of Boehringer Ingelheim Pharmaceuticals
Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy
A triple-action Formula for comprehensive respiratory relief
mRNA-1010 demonstrated superior relative vaccine efficacy
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month
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