HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe
Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.
The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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