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1495 News Found

Center for Breakthrough Medicines launches analytical testing
Biotech | February 17, 2022

Center for Breakthrough Medicines launches analytical testing

More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline


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


Swissmedic  approves BeiGene's Brukinsa
Drug Approval | February 17, 2022

Swissmedic approves BeiGene's Brukinsa

With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain


Pebble engages MD Anderson to evaluate multi-cannabinoid formulations in ovarian cancer
Biotech | February 17, 2022

Pebble engages MD Anderson to evaluate multi-cannabinoid formulations in ovarian cancer

Despite advances over the past 20 years, ovarian cancer treatment requires better standard of care


USFDA approves Lupin’s Supplemental New Drug Application for Solosec
Drug Approval | February 17, 2022

USFDA approves Lupin’s Supplemental New Drug Application for Solosec

The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV


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


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


Lantern Pharma collaborates with GCCRI for pediatric cancer
Biotech | February 16, 2022

Lantern Pharma collaborates with GCCRI for pediatric cancer

Dr. Peter Houghton will lead the research collaboration for GCCRI and is widely regarded as a leading expert in pediatric cancer research and in the development of novel approaches to treating childhood cancers


Lynparza plus abiraterone effective in standard-of-care in 1st-line metastatic castration-resistant prostate cancer
Biotech | February 15, 2022

Lynparza plus abiraterone effective in standard-of-care in 1st-line metastatic castration-resistant prostate cancer

These results will be presented on 17 February at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium


Glenmark to commercialize AstraZeneca’s asthma drug in Columbia
Biotech | February 14, 2022

Glenmark to commercialize AstraZeneca’s asthma drug in Columbia

AstraZeneca will hold the registration and manufacture Pulmicort Respules, while Glenmark will commercialize the product in Columbia