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Results For "design"

1661 News Found

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Drug Approval | February 20, 2022

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear


Rapid Medical receives USFDA designation for Comaneci
Medical Device | February 16, 2022

Rapid Medical receives USFDA designation for Comaneci

The device will facilitate the treatment of cerebral vasospasm following hemorrhagic stroke


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation


USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Drug Approval | February 10, 2022

USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences

Adds five years of market exclusivity on approval


Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine
Biotech | January 04, 2022

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine

BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


ICMR Dibrugarh designs kit to detect Omicron variant in two hours
News | December 13, 2021

ICMR Dibrugarh designs kit to detect Omicron variant in two hours

GCC Biotech is manufacturing the kits on a public-private partnership (PPP) model


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications