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Results For "tolerability"

237 News Found

NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis
News | December 07, 2024

NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis

Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator


Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


Ichnos Glenmark Innovation to present Phase 1 study of Trispecific ISB 2001 in r/rMM at ASH Annual Meeting
Clinical Trials | November 07, 2024

Ichnos Glenmark Innovation to present Phase 1 study of Trispecific ISB 2001 in r/rMM at ASH Annual Meeting

ISB 2001 demonstrated a favorable safety and tolerability profile, and an overall response rate (ORR) of 75% in r/r MM


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months
Clinical Trials | September 27, 2024

BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months

At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Suven Life Sciences announces positive topline results from Phase-2 PoC signal detection open label study of Ropanicant
News | September 18, 2024

Suven Life Sciences announces positive topline results from Phase-2 PoC signal detection open label study of Ropanicant

The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD