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2920 News Found

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


Top five pharma looks to LifeSphere IDMP for regulatory readiness
News | February 18, 2022

Top five pharma looks to LifeSphere IDMP for regulatory readiness

ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness


Quotient Sciences integrates drug substance into Translational Pharmaceutics Platform
Biotech | February 18, 2022

Quotient Sciences integrates drug substance into Translational Pharmaceutics Platform

The newly enhanced drug development platform will help empower innovators with the fastest development timelines


Bayer raises peak sales for Nubeqa to exceed €3 billion
News | February 18, 2022

Bayer raises peak sales for Nubeqa to exceed €3 billion

Darolutamide is developed jointly by Bayer and Orion Corporation


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


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 announces expansion in key Asian markets
News | February 16, 2022

Moderna announces expansion in key Asian markets

New subsidiaries to be established in Malaysia, Taiwan, Singapore, and Hong Kong


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


Proactive For Her raises US $ 5.5 million in Series A Round
Startup | February 16, 2022

Proactive For Her raises US $ 5.5 million in Series A Round

The funds will be used to expand digital product offerings, grow their online customer base, and launch their flagship clinic in Bengaluru


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