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Results For "U.S"

1563 News Found

US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


LEO Pharma appoints Brian Hilberdink President of LEO Pharma, US
People | February 18, 2022

LEO Pharma appoints Brian Hilberdink President of LEO Pharma, US

Brian joins LEO Pharma from Novo Nordisk, U.S. where he served as Senior Vice President of Sales.


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


Health Canada authorizes Novavax Covid-19 vaccine
News | February 18, 2022

Health Canada authorizes Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Canada


Evonik invests in start-up to improve patient recovery after open-chest surgery
Startup | February 18, 2022

Evonik invests in start-up to improve patient recovery after open-chest surgery

Evonik invests in start-up to improve patient recovery after open-chest surgery


AptarGroup reported 2021 sales at US $3.23 billion
News | February 18, 2022

AptarGroup reported 2021 sales at US $3.23 billion

AptarGroup acquired Voluntis and 80% of Weihai Hengyu Medical Products in 2021.


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


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


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