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Results For "SFDA"

1445 News Found

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat
Drug Approval | August 16, 2023

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat

Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus


Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr
News | August 09, 2023

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr

US FDA approval is in line with de-risking strategy for additional API site to service our global customer base


Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma
Drug Approval | August 06, 2023

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated


NATCO files generic Erdafitinib Tablets in USA
Drug Approval | July 26, 2023

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma


Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories
Drug Approval | July 20, 2023

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial


Granules India announces approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | July 14, 2023

Granules India announces approval for Acetaminophen and Ibuprofen Tablets

This product will be launched through Granules Consumer Health (GCH) division


Briefs: Link Pharma Chem and Zydus
News | July 11, 2023

Briefs: Link Pharma Chem and Zydus

USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad


Astellas receives FDA priority review for Zolbetuximab biologics license application
Drug Approval | July 10, 2023

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer
Drug Approval | June 20, 2023

Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer

This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable


Lupin launches Thiamine Hydrochloride Injection USP in the US
Drug Approval | June 19, 2023

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.