Regulatory & Policy
FDA Grants Sanofi's Venglustat Breakthrough Therapy Designation for Type 3 Gaucher Disease Treatment
Sanofi (EURONEXT: SAN; NASDAQ: SNY), a Paris-headquartered biopharma company, announced that the US FDA has granted Breakthrough Therapy designation to...
FDA Grants Hemab Therapeutics Breakthrough Therapy Designation for Sutacimig in Glanzmann Thrombasthenia
Hemab Therapeutics, a late-stage clinical biotechnology company headquartered in Cambridge, Massachusetts, and Copenhagen, Denmark, announced that the U.S....
FDA Resumes Review of Capricor's Deramiocel for Duchenne Muscular Dystrophy Cardiomyopathy
The US FDA has resumed review of a Biologics License Application (BLA) from Capricor Therapeutics for Deramiocel (CAP-1002), an allogeneic...
NMPA Approves IND for HBM7575/SKB575 by Harbour BioMed and Kelun-Biotech in Atopic Dermatitis
China's NMPA Clears IND for HBM7575/SKB575, a Bispecific Antibody Targeting TSLP in Atopic Dermatitis
SciSparc Secures US Patent for Cannabinoid-Enhanced Antimicrobial Technology Against MRSA
NeuroThera Labs, a majority-owned subsidiary of SciSparc Ltd. (Nasdaq: SPRC), has been granted a significant U.S. patent covering a novel cannabinoid-enhanced platform designed to combat antimicrobial resistance, particularly against challenging pathogens like Methicillin-resistant Staphylococcus aureus (MRSA). The United States Patent and Trademark Office issued the patent, which protects a groun
Calico Life Sciences' ABBV-CLS-628 secures US FDA Fast Track designation for ADPKD treatment
Calico Life Sciences LLC, a biotechnology company founded by Alphabet Inc., [announced](https://www.prnewswire.com/news-releases/calico-life-sciences-announces-us-fda-fast-track-designation-for-investigational-treatment-of-autosomal-dominant-polycystic-kidney-disease-302573172.html) on October 2, 2025 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ABBV-CLS-6
Ichnos Glenmark Innovation's ISB 2001 secures US FDA Fast Track designation for multiple myeloma
Ichnos Glenmark Innovation (IGI) [announced](https://www.prnewswire.com/news-releases/ichnos-glenmark-innovation-igi-receives-us-fda-fast-track-designation-for-isb-2001-for-relapsedrefractory-multiple-myeloma-302445918.html) today that the US FDA has granted Fast Track designation for ISB 2001, an investigational trispecific antibody targeting relapsed or refractory multiple myeloma (RRMM) in adul
NS Pharma's NS-229 secures US FDA Fast Track designation for eosinophilic granulomatosis with polyangiitis
NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd., [announced](https://www.prnewswire.com/news-releases/fda-grants-fast-track-designation-to-ns-229-for-the-treatment-of-eosinophilic-granulomatosis-with-polyangiitis-302550236.html) on Sept. 9, 2025 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NS-229, an investigational selective Janus kinase 1 (JAK
FDA Approval
FDA Approves First Therapy for Rare Genetic Copper Transport Disorder The U.S. Food and Drug Adminis...
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