Recently Featured

NorthSea Therapeutics Secures Orphan Drug Designations for Orziloben from FDA and EMA

March 12, 2026
NorthSea Therapeutics B.V. has achieved significant regulatory milestones with the US FDA and the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) granting Orphan Drug Designations (ODD) to orziloben (NST-6179) for the treatment of intestinal failure associated liver disease (IFALD). This recognition underscores the urgent need for effective treatments in the realm of…

Esperion to Acquire Corstasis for $75M, Expanding Portfolio with Unique Nasal Diuretic

March 11, 2026
Esperion Therapeutics has announced its intention to acquire Corstasis Therapeutics for $75 million, a strategic move that positions the company to enhance its product offerings in the cardiovascular space. Corstasis is the developer of Enbumyst, the only nasally administered diuretic approved in the United States, which received regulatory approval in September for the treatment of…

Acadia, undaunted by recent EU rejection, seeks CHMP re-examination of Rett syndrome med Daybue

March 11, 2026
Acadia Pharmaceuticals has formally requested a re-examination of its application for Daybue, a treatment for Rett syndrome, by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This move comes in the wake of a rejection in late February, where the CHMP cited significant concerns regarding the pivotal trial data supporting the…

FDA’s CRLs reveal critical errors in AstraZeneca’s Saphnelo data, efficacy doubts for GSK’s Exdensur

March 11, 2026
The FDA has recently published complete response letters (CRLs) for AstraZeneca’s Saphnelo and GSK’s Exdensur, revealing significant deficiencies in the data submitted for review. These letters indicate that AstraZeneca’s application contained critical errors that raise questions about the robustness of the clinical data supporting Saphnelo’s efficacy and safety profile. Similarly, GSK faces scrutiny as the…

Ongoing Cases