Tags : Fast Track Designation

LEO Pharma Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions […]Read More

Pfizer with its Partner BioNTech Receives the US FDA’s Fast

Shots: The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul 01, 2020. Additionally, the early results of German trial evaluating BNT162b1 are expected in Jul 2020 The companies BNT162 mRNA-based vaccine program involves the evaluation of 4 investigational candidates developed to target […]Read More

Moderna’s mRNA-1273 Receives the US FDA’s Fast Track Designation to

Shots: The US FDA has granted the FT designation to the Moderna’s mRNA vaccine (mRNA-1273) candidate against COVID-19. FT designation is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need On May 06, 2020, the FDA has completed its review of mRNA-1273’s […]Read More

Alnylam’s Vutrisiran Receives the US FDA’s Fast Track Designation to

Shots: The US FDA has granted FT designation vutrisiran for treating polyneuropathy of hATTR amyloidosis in adults. The designation allows Alnylam to submit NDA for vutrisiran The P-I study assessing Vutrisiran (quarterly dosing with low-volume, SC) demonstrated a reduction in the burden of care for the disease. The safety & efficacy of the therapy are […]Read More

Soligenix’s RiVax Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to RiVax (heat stable ricin toxin vaccine) to prevent ricin intoxication. Soligenix will submit BLA for the vaccine on a rolling basis, letting the FDA review sections of the BLA prior to receiving the complete submission FDA’s FT designation is intended to facilitate the development and expedite […]Read More

Alector’s AL101 Receives FDA’s Fast Track Designation to Treat Frontotemporal

Shots: The US FDA has granted FT designation to Alector’s AL101 to treat patients with progranulin gene mutations causative of frontotemporal dementia (FTD-GRN), currently being evaluated in P-I study in healthy volunteers The FDA’s FT designation is designed to facilitate the development and expedite the review of therapies for serious conditions targeting unmet medical needs […]Read More

Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients

Shots: The US FDA has granted FT designation to APD418, currently in development for the treatment of DHF  The FDA’s Fast Track designation facilitate the development and expedite the review of therapy to treat serious conditions and fill an unmet medical need APD418 is a first-in-class β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, designed to […]Read More

Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse

Shots: The US FDA has granted FT designation to Triumvira’s TAC01-CD19 for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) prior treated with at least two systemic therapies The TAC technology will significantly improve the limitation of existing cell therapies, including the risk of cytokine release syndrome and neurotoxicity, expanding treatment option for […]Read More

Astellas’ ASP1128 Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery In 2018, Astellas acquired Mitobridge to focus on developing mitochondrial-directed therapies and recognizes the serious burden of AKI on patients. […]Read More