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Results For "Phase-II"

570 News Found

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease
News | October 14, 2024

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease

The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease


AGC Biologics begins operations at new manufacturing building in Copenhagen
News | October 14, 2024

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors


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


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