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This regulatory status is designed for therapies targeting rare, life-threatening, or chronically debilitating diseases.
Cushing’s syndrome of endogenous origin is a rare endocrine disease caused in most instances by excessive production of adrenocorticotropic hormone (ACTH).
This is often due to a pituitary tumour known as Cushing’s disease, or less frequently ...
This decision makes Orzeyful the only treatment in Japan currently indicated to address the underlying cause of narcolepsy type 1, also known as narcolepsy with cataplexy, rather than targeting individual symptoms.
Orzeyful, an oral orexin receptor 2 agonist, was discovered in Takeda’s laboratories in Japan.
Takeda is preparing to launch the therapy in Japan, ai...
This decision provides a new therapeutic option for patients who have received at least one previous treatment.
Teclistamab is a bispecific antibody administered via subcutaneous injection. It targets B-Cell Maturation Antigen (BCMA) and cluster of differentiation 3 (CD3), prompting an immune response against cancer.
Johnson & Johnson EMEA haematology therap...
Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The private investment comprises an initial closing, a subsequent closing contingent upon FDA acceptance of a new drug application (NDA) for seralutinib in PAH and warrants exercisable upon FDA approval.
<...The development marks the next stage of a partnership that began in 2017 and saw further expansion in 2021.
Over the last five years, more than 1,300 WellSpan patients at 12 cancer sub-specialties have received support from the partnership, which includes physician consultations, multidisciplinary tumour conferences, and access to subspecialty expertise.
Around ...