The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9
The study observed 2,648 girls, of which 2,300 completed the standard 45-day programme
The recent inspection covered both cGMP and PAI processes
Phase 3 study results will form the basis for future discussions with global regulatory authorities
The new Injectable Facility housed in Akums Healthcare started commercial production on 22nd August 2024, with a capacity of 362 million units annually
Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Higher revenues backed by huge demand and expanding network contributed to the growth in bottom line
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
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