orphan drug designation

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.

Daily22h

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 ...

23h

Zydus Life rises after USFDA grants orphan drug status to Usnoflast for ALS treatment

Zydus Lifesciences added 1.10% to Rs 987.60 after the company said that the USFDA had granted orphan drug designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic ...

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 ...