Regulatory & Policy
FDA approves Rhythm Pharmaceuticals' Imcivree for acquired hypothalamic obesity in adults and children
The US FDA has approved an expanded indication for IMCIVREE (setmelanotide), developed by Rhythm Pharmaceuticals, to treat acquired hypothalamic obesity in...
FDA Approves Bristol Myers Squibb's Sotyktu for Active Psoriatic Arthritis in Adults
The US FDA has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, Bristol Myers Squibb announced on 6 March...
MetaVia secures global patent portfolio for DA-1726 dual agonist obesity therapy through 2041
MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company headquartered in the US, announced on February 13, 2026, that it has assembled a...
AnaCardio and Helsinn secure US patent for AC01 calcium sensitizing heart failure treatment
AnaCardio AB (Sweden), a clinical-stage biopharmaceutical company developing contractile agents for heart failure, and its partner Helsinn Healthcare SA...
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...
AnnJi Pharmaceutical's AJ201 Secures US FDA Fast Track Designation for Kennedy's Disease Treatment
FDA Grants Fast Track Designation to Promising Kennedy's Disease Treatment
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...
Drug Farm's DF-003 Secured US FDA Orphan Drug Designation for ROSAH Syndrome
Drug Farm, a private biotechnology company with operations in Albany, New York, and Shanghai, announced that the U.S. Food and Drug Administration (FDA) has...
FDA Grants ENHERTU Priority Review for HER2-Positive Early Breast Cancer Post-Neoadjuvant Treatment
Daiichi Sankyo Co., Ltd. (TSE: 4568), headquartered in Tokyo, and AstraZeneca (LSE/STO/NYSE: AZN), headquartered in Cambridge, UK, announced that the U.S....
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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