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Results For "USFDA"

1312 News Found

Pfizer announces Talzenna and Xtandi combination data from phase 3 study
News | February 18, 2023

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI


Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Drug Approval | February 18, 2023

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million


Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing
Drug Approval | February 18, 2023

Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing

Themis will market this drug with the brand name REMITHEM.


Briefs: Piramal Pharma, Alembic Pharmaceuticals
News | February 17, 2023

Briefs: Piramal Pharma, Alembic Pharmaceuticals

USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA


Shilpa Medicare Unit VI Bengaluru facility registered with Ministry of Health, UAE
News | February 17, 2023

Shilpa Medicare Unit VI Bengaluru facility registered with Ministry of Health, UAE

This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization


FDA approves Pfizer's supplemental new drug application for CIBINQO
Drug Approval | February 14, 2023

FDA approves Pfizer's supplemental new drug application for CIBINQO

Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Lupin Q2 FY23 revenue up 3.9%; Profit down 71%
News | February 10, 2023

Lupin Q2 FY23 revenue up 3.9%; Profit down 71%

With the recent sales force expansion and new product launches, we expect to be back to above-market growth


Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection
Drug Approval | February 02, 2023

Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities


Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America