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Results For "Serious-Adverse-Event"

79 News Found

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Clinical Trials | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


Pfizer updates on Phase 3 study of investigational gene therapy for ambulatory boys with Duchenne Muscular Dystrophy
Clinical Trials | June 13, 2024

Pfizer updates on Phase 3 study of investigational gene therapy for ambulatory boys with Duchenne Muscular Dystrophy

The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment at one year after treatment


Lily announces positive gene therapy result for genetic hearing loss
Clinical Trials | January 25, 2024

Lily announces positive gene therapy result for genetic hearing loss

Hearing restoration was observed within 30 days of a single administration of AK-OTOF in the initial AK-OTOF-101 study participant


Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873
News | December 12, 2023

Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873

The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe


BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint
Clinical Trials | August 29, 2023

BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint

Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year / At one-year


Moderna presents Phase 1/2 of MRNA-3927at 2023 ASGCT Meeting
Clinical Trials | May 20, 2023

Moderna presents Phase 1/2 of MRNA-3927at 2023 ASGCT Meeting

First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


Zydus granted Orphan Drug Designation by USFDA for ZYIL1
Drug Approval | March 22, 2023

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates


Diabetic neuropathic pain field presents significant opportunity for drug developers, says GlobalData
Healthcare | December 20, 2022

Diabetic neuropathic pain field presents significant opportunity for drug developers, says GlobalData

36.4% of patients with diabetic neuropathic pain in 2021 were completely treatment refractory and would benefit from new treatment options.


CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares
News | October 17, 2022

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in