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3326 News Found

Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


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


Centauri Therapeutics closes £ 24 million Series A investment round
Startup | February 17, 2022

Centauri Therapeutics closes £ 24 million Series A investment round

Funding will support continued advancement of Centauri’s antimicrobial resistance research to identify novel therapeutic candidates using its proprietary Alphamer platform


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


Rapid Medical receives USFDA designation for Comaneci
Medical Device | February 16, 2022

Rapid Medical receives USFDA designation for Comaneci

The device will facilitate the treatment of cerebral vasospasm following hemorrhagic stroke


GOQii raises US $ 50 million Series C funding
Startup | February 16, 2022

GOQii raises US $ 50 million Series C funding

Funding to grow the insurance and digital therapeutics vertical in India


BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies
interviews | February 15, 2022

BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies

BDR Pharmaceuticals is a home-grown company with operations in India and overseas. It’s known for its formulations portfolio and has a presence in specialty medicines. The company has ambitious plans as it has ramped up capacity and looking to foray into regulated markets. Raheel Shah, Director, BDR Group of Companies shares his insights in an interview with Thomas C Thottathil, Editor, Indian Pharma Post


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation