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350 News Found

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Merck updates on Phase 3 MOVe-AHEAD trial evaluating Lagevrio
News | February 22, 2023

Merck updates on Phase 3 MOVe-AHEAD trial evaluating Lagevrio

The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData
News | January 27, 2023

Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData

The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.


Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain
News | January 10, 2023

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)


Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases
Clinical Trials | January 06, 2023

Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases

Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise


Hetero's COVID-19 oral drug gets WHO prequalification
News | December 27, 2022

Hetero's COVID-19 oral drug gets WHO prequalification

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission


European Commission approves SPEVIGO for generalized pustular psoriasis flares
Drug Approval | December 13, 2022

European Commission approves SPEVIGO for generalized pustular psoriasis flares

EC grants conditional marketing authorization based on the EFFISAYIL trial


Takeda’s dengue vaccine QDENGA approved for use in EU
Drug Approval | December 09, 2022

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)