Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
European markets now contribute 51% of our business revenue up from 43% in Q4 FY24 and 34% in Q1 FY24
The results are an outcome of the company's focus on sustainable and profitable growth and reflects all the hard work and focus teams have put in over the years
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Decision on EU marketing authorisation for this population expected by September 2024
Access to breast milk for sick newborns admitted in intensive care units plays a lifesaving role
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
The transaction aligns with Lupin's strategy to grow its global presence in Specialty areas
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