PharmaTimes21h
Zydus announces USFDA Orphan Drug Designation for Usnoflast in ALS treatment
Zydus has announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for ...
Contract Pharma16h
FDA Grants Orphan & Rare Pediatric Designations to Tikun’s FD Treatments
The goal is to treat familial dysautonomia patients with a single injection.
Daily23h
Zydus Usnoflast gets USFDA Orphan Drug Designation for amyotrophic lateral sclerosis
Ahmedabad: Zydus, a discovery-based, global pharmaceutical company has announced that the U.S. Food and Drug Administration ...
Pharmaceutical Technology16h
FDA grants ODD status to Zai Lab’s lung cancer treatment
The FDA has granted orphan drug designation (ODD) to Zai Lab’s ZL-1310, aimed at treating small cell lung cancer (SCLC).
ophthalmologytimes19h
FDA grants fast track designation to N-acetylcysteine amide tablets from Nacuity Pharmaceuticals
The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...
The Pharma Letter18h
GlobalData tracks 40 years of innovation in FDA review designations
Regulatory authorities, particularly the US Food and Drug Administration (FDA), have played a crucial role in accelerating and incentivizing the development of innovative treatments through review ...
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, ...
GlobalData on MSN16h
Intellia doses first subject in trial of NTLA-2002 for hereditary angioedema
The HAELO trial will assess the therapy’s safety and efficacy in 60 adult subjects with Type I or Type II HAE.
ALX Oncology Shares Drop 15% Following Positive Phase 2
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Pharmabiz1h
Jaguar Health begins patient dosing in investigator-initiated POC trial of crofelemer for rare disease indication of MVID
San Francisco, California Friday, January 24, 2025, 11:00 Hrs [IST] ...
appliedclinicaltrialsonline9h
First Patient Dosed in Phase II Expansion Portion of Acclaim-3 Trial of Reqorsa in Combination With Tecentriq
In the Phase I dose escalation portion, which evaluated the combination in participants with small cell lung cancer, the first patient treated attained partial remission.