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Results For "EMA"

2776 News Found

DCGI approves AstraZeneca 's Olaparib film-coated tablets
Drug Approval | August 20, 2022

DCGI approves AstraZeneca 's Olaparib film-coated tablets

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer


Shilpa Medicare completes clinical studies of high concentration biosimilar Adalimumab
Clinical Trials | August 20, 2022

Shilpa Medicare completes clinical studies of high concentration biosimilar Adalimumab

The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


WuXi STA breaks ground for second manufacturing facility in US
News | August 19, 2022

WuXi STA breaks ground for second manufacturing facility in US

This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region


QPharma launches Ti OrderPoint 2
Digitisation | August 19, 2022

QPharma launches Ti OrderPoint 2

OrderPoint was designed as an advanced DTR solution from its first release in 2016.


Jemincare inks licensing deal for prostate cancer drug with Roche
News | August 19, 2022

Jemincare inks licensing deal for prostate cancer drug with Roche

Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.


Growing investment in biotech startups likely to make CAR-T therapies affordable in India, says GlobalData
Startup | August 19, 2022

Growing investment in biotech startups likely to make CAR-T therapies affordable in India, says GlobalData

GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.


NATCO announces tentative approval to its ANDA for Trabectedin
Drug Approval | August 18, 2022

NATCO announces tentative approval to its ANDA for Trabectedin

According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.


Sanofi updates on amcenestrant clinical development program
Clinical Trials | August 18, 2022

Sanofi updates on amcenestrant clinical development program

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial


FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations