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315 News Found

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo


Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’
Drug Approval | July 26, 2024

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials


Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC
Clinical Trials | July 23, 2024

Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC

Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT


Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
News | June 22, 2024

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population


Pfizer reports positive results from Echelon-3 study
Clinical Trials | June 17, 2024

Pfizer reports positive results from Echelon-3 study

Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone


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


Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis
Clinical Trials | June 09, 2024

Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis

New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH


Bayer and Samsung take action against sleep disturbances associated with menopause
News | June 06, 2024

Bayer and Samsung take action against sleep disturbances associated with menopause

Sleep disturbances are among the most frequent and disruptive symptoms associated with menopause which can impact women’s health and quality of life


Pfizer’s ADCETRIS regimen produces clinically meaningful improvement in overall survival in patients with DLBCL
Clinical Trials | June 04, 2024

Pfizer’s ADCETRIS regimen produces clinically meaningful improvement in overall survival in patients with DLBCL

Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen