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Results For "USFDA"

1130 News Found

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.


Lupin receives EIR from FDA for its API manufacturing facility in Vizag
Drug Approval | June 19, 2023

Lupin receives EIR from FDA for its API manufacturing facility in Vizag

The inspection closed with the facility receiving an inspection classification of NAI


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


Briefs: Natco Pharma and Panacea Biotec
Drug Approval | June 16, 2023

Briefs: Natco Pharma and Panacea Biotec

Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products


Granules India received ANDA approval for Metoprolol Succinate ER Tablets
Drug Approval | June 14, 2023

Granules India received ANDA approval for Metoprolol Succinate ER Tablets

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.