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Home»Posts tagged with»EMA MAA

No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review

By Pallavi Madhiraju on March 7, 2026   Pharma & Biotech  

No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review

Savara’s molgramostim BLA faces no FDA adcom. Analysis of what the August 2026 PDUFA date means for autoimmune PAP treatment access. Read more.

Corcept’s relacorilant CRL leaves endocrinology ambitions in limbo as oncology pivot takes center stage

By Pallavi Madhiraju on January 1, 2026   Pharma & Biotech  

Corcept’s relacorilant CRL leaves endocrinology ambitions in limbo as oncology pivot takes center stage

Find out why FDA’s complete response letter for Corcept’s relacorilant could reshape treatment of hypercortisolism, with implications for oncology approval.

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