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Results For "FDA-approval"

460 News Found

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346
News | December 10, 2023

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346

First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes


Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Innocan Pharma reports discovery regarding its LPD platform and global CBD research
News | October 25, 2023

Innocan Pharma reports discovery regarding its LPD platform and global CBD research

The company expects that this development could improve the strength of its application to the FDA for new drug approval


USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis
Drug Approval | October 20, 2023

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials


GlobalData predicts product cannibalization within electrophysiology ablation space
News | October 12, 2023

GlobalData predicts product cannibalization within electrophysiology ablation space

PFA technology is only marketed in Europe, and yet, it has been dominating the electrophysiology market by storm


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia
Drug Approval | September 19, 2023

Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia

Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy


AI to transform all processes in drug development by 2026, predicts CPHI Report
Digitisation | September 13, 2023

AI to transform all processes in drug development by 2026, predicts CPHI Report

In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs