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927 News Found

GSK pauses phase III RSV maternal vaccine candidate programme
News | February 20, 2022

GSK pauses phase III RSV maternal vaccine candidate programme

This decision does not impact the ongoing AReSVi 006 phase III trial for RSV older adults.


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades


WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients
Drug Approval | February 20, 2022

WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients

Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra


Tremfya achieves greater clinical responses in patients with ulcerative colitis
Biotech | February 19, 2022

Tremfya achieves greater clinical responses in patients with ulcerative colitis

Data from the Phase 2b QUASAR Induction Study showed approximately 60% of patients achieved the primary endpoint of clinical response, and approximately 30% showed endoscopic improvement with TREMFYA treatment compared with placebo


Moderna’s Covid-19 vaccine approved in Australia for children (6-11 years)
News | February 17, 2022

Moderna’s Covid-19 vaccine approved in Australia for children (6-11 years)

Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia


Kato wins USFDA approval for studies in retinal disorder
Biotech | February 17, 2022

Kato wins USFDA approval for studies in retinal disorder

Resolv ER may remedy leading causes of blindness in adults


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine
Biotech | February 16, 2022

EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine

Apexxnar is the first pneumococcal conjugate vaccine to help protect adults ages 18 years and older against 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia


CDSCO recommends EUA for Corbevax in age group 12-18 years
News | February 15, 2022

CDSCO recommends EUA for Corbevax in age group 12-18 years

The recommendation has been sent to the DCGI for approval


Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19
Drug Approval | February 14, 2022

Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19

Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data