Ips Heart Inc. has been awarded orphan drug designation by the FDA for its GIVI-MPC stem cell therapy for Becker muscular dystrophy. GIVI-MPC has the unique ability to create new muscle with full length dystrophin in Becker muscular dystrophy.
Pulsesight Therapeutics SAS has submitted a clinical trial authorization (CTA) to the French authority ANSM seeking to conduct a first-in-human phase I trial of PST-611 for dry age-related macular degeneration (AMD)/geographic atrophy (GA).
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYS-6041, an antibody-drug conjugate, for advanced solid tumors.
Quanta Therapeutics Inc. has gained IND clearance from the FDA for QTX-3544, an oral multi-KRAS inhibitor with G12V-preferring activity and dual ON/OFF state.
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
CSPC Pharmaceutical Group Ltd. has gained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2062 injection, a double-stranded small interfering RNA (siRNA) drug to treat hypertension.
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