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Results For "U.S"

1563 News Found

Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business
News | November 30, 2022

Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business

To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Clinical Trials | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP
Drug Approval | November 15, 2022

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

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


Biocon Biologics features on ASIA IP ELITE List 2022
News | November 14, 2022

Biocon Biologics features on ASIA IP ELITE List 2022

This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets
Drug Approval | November 03, 2022

Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.


Aptar Pharma completes Phase I global injectables expansion program
News | November 01, 2022

Aptar Pharma completes Phase I global injectables expansion program

The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.


Glenmark Pharmaceuticals launches Fingolimod Capsules in US
News | November 01, 2022

Glenmark Pharmaceuticals launches Fingolimod Capsules in US

According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Lupin launches Paliperidone Extended-Release Tablets in US
News | October 24, 2022

Lupin launches Paliperidone Extended-Release Tablets in US

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).