Shots:The EC has approved Zurzuvae (zuranolone) for the treatment of postpartum depression in adults following MHRA’s approval in Aug 2025Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depressionTrial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
Shots:The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depressionTrial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
Biosimilars are going in market with vast emerging needs of people for multiple diseases. The biologics that are too costly to be used in the markets. Hence physicians are developing biosimilars a reference product to biologics which are biologically similar to biologics. Our team at PharmaShots have summarized some of the news regarding biosimilars in…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies…

