USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
US FDA approval based on NEURO-TTRansform Phase III results
First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
The company expects that this development could improve the strength of its application to the FDA for new drug approval
Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials
PFA technology is only marketed in Europe, and yet, it has been dominating the electrophysiology market by storm
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs
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