The US Food and Drug Administration (FDA) has accepted Crinetics Pharmaceuticals' paltusotine new drug application (NDA) as a long-term maintenance and potential treatment for acromegaly in the adult population.
Torii Pharmaceutical has submitted a new drug application (NDA) for TO-208 in Japan, targeting the treatment of molluscum contagiosum, a common and highly contagious skin disease.
Mind Medicine (MindMed) has received the innovation passport designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its MM120 Orally Disintegrating Tablet (ODT) as a potential treatment for generalised anxiety disorder (GAD).
Theratechnologies has entered into a licensing agreement with Ionis Pharmaceuticals to acquire exclusive Canadian rights for two investigational RNA-targeted medicines, olezarsen and donidalorsen.
Gilead Sciences has entered into an exclusive option and license agreement with German biotechnology company Tubulis to develop an antibody-drug conjugate (ADC) aimed at treating solid tumours.
The Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted orphan drug designation to Renalys Pharma’s sparsentan, which is intended for the treatment of primary IgA nephropathy (IgAN).
The Department of Health of the Hong Kong Special Administrative Region, China, has accepted the new drug application (NDA) for oral VELSIPITY (etrasimod) submitted by Everest Medicines, for treating adults with moderately to severely active ulcerative colitis (UC).
Dr. Reddy's Laboratories has launched Toripalimab, the only immuno-oncology drug approved by global regulatory authorities for the treatment of nasopharyngeal carcinoma (NPC), in India.
Valneva has submitted an application to the US Food and Drug Administration (FDA) seeking approval for a label extension of its chikungunya vaccine, IXCHIQ.
The US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) of Alnylam Pharmaceuticals’ vutrisiran for review.
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