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7182 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).


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


Interactive App from rXperius to provide pharma industry with patient insights
Digitisation | February 18, 2022

Interactive App from rXperius to provide pharma industry with patient insights

The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences


USFDA clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope


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.


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.


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


IPP to organize e-conference on 'Indian Pharma Industry: Developing a conducive ecosystem' on Feb 18
News | February 17, 2022

IPP to organize e-conference on 'Indian Pharma Industry: Developing a conducive ecosystem' on Feb 18

The speakers for the e-conference are: Dr. Mukund Chorgade, President/CSO, THINQ Pharma; Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance; Jayaseelan J., National Vice President (Industry Division), Indian Pharmaceutical Association; Spandan Mishra who is Director- Sales, Customer Service & Logistics for Evonik India, Nepal & Sri Lanka region; Dr. Kommu Nagaiah, Chief Scientist & Head, CSIR-IICT; Govind K. Jaju, Partner, Suingora Consulting; nd Pravin Prashant, Executive Editor, Indian Pharma Post & Editor, Indian Chemical News.


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