Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 94

Results For "U.S"

1563 News Found

Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension
Drug Approval | July 05, 2023

Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension

Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)


Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Drug Approval | July 04, 2023

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)


Biocon Biologics' Hulio Biosimilar to Humira now available in the US
News | July 04, 2023

Biocon Biologics' Hulio Biosimilar to Humira now available in the US

The launch of HULIO in the United States is an important milestone for Biocon Biologics


Granules India successfully completes Two US FDA Audits in a span of 2 weeks
Drug Approval | July 03, 2023

Granules India successfully completes Two US FDA Audits in a span of 2 weeks

The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.


Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide shows nearly 19% weight loss in people with obesity
News | June 28, 2023

Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide shows nearly 19% weight loss in people with obesity

Survodutide has a novel mechanism of action (agonism of the dual GCG/GLP-1 receptors) that may have direct effects on energy expenditure in the liver in addition to decreasing appetite


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands


Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata
Drug Approval | June 27, 2023

USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata

LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12


Moderna files for FDA authorization of its Covid-19 Vaccine
Drug Approval | June 27, 2023

Moderna files for FDA authorization of its Covid-19 Vaccine

Supply readiness follows months of manufacturing to ensure timely and ample supply


Polyplastics announces commercial availability of DURACON POM PM Series for medical industry
News | June 23, 2023

Polyplastics announces commercial availability of DURACON POM PM Series for medical industry

The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.