Regulatory Disc’s FDA meeting sets ‘clear path’ for embattled rare blood disease drug BioSpaceThe FDA rejected bitopertin in February amid reports of skepticism from former CBER director Vinay Prasad, who has since departed the agency.Rare DiseaseRead full story pharminent June 10, 2026 (Last updated: June 10, 2026) BioSpace The FDA rejected bitopertin in February amid reports of skepticism from former CBER director Vinay Prasad, who has since departed the agency. Rare Disease Read full story Post navigation Previous: Bayer’s asundexian starts EU review for ischaemic strokeNext: Lilly wins new FDA approval for eczema drug Ebglyss Related Stories Regulatory Ultragenyx wins FDA approval for first treatment targeting root cause of GSDIa pharminent August 20, 2026 Regulatory Regeneron wins FDA approval to challenge Ipsen for rare bone disease market pharminent August 20, 2026 Regulatory FDA grants accelerated approval to Ultragenyx’s Genglycos gene therapy pharminent August 20, 2026