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Results For "Phase-II"

537 News Found

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


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


Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun
News | October 02, 2024

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun


Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
Drug Approval | September 29, 2024

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)


Decline in TB incidence by 16% from 237 per hundred thousand population in 2015 to 199 in 2022
News | September 25, 2024

Decline in TB incidence by 16% from 237 per hundred thousand population in 2015 to 199 in 2022

She reiterated the nation's commitment to eliminating TB as a public health problem by 2030 and ensuring a healthier future for all


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


Wacker collaborates with MinervaX for prophylactic vaccine targeting Group B streptococcus
News | September 17, 2024

Wacker collaborates with MinervaX for prophylactic vaccine targeting Group B streptococcus

Wacker Biotech will manufacture the active ingredients of MinervaX’s novel vaccine candidate


Wockhardt wins “BIRAC Innovator Award 2024”
News | September 16, 2024

Wockhardt wins “BIRAC Innovator Award 2024”

The award is for development of Nafithromycin, which is the first ever multi-drug resistant pathogen active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia


Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression
Clinical Trials | September 04, 2024

Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression

New Phase II data show vast majority of patients experiencing no relapses or disability progression


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration