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Results For "USFDA"

1355 News Found

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.


Zydus announces Phase IV EVIDENCES-XI trial to generate Real World Evidence of Saroglitazar Mg in NAFLD patients with comorbidities
Clinical Trials | June 10, 2023

Zydus announces Phase IV EVIDENCES-XI trial to generate Real World Evidence of Saroglitazar Mg in NAFLD patients with comorbidities

The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52


Briefs: Ipca Laboratories, Lupin and Zydus
News | June 05, 2023

Briefs: Ipca Laboratories, Lupin and Zydus

The company has extended its full co-operation and support to the officials of the Income Tax Department


Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
News | May 15, 2023

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations


Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023
News | May 10, 2023

Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023

The Awards recognizes standout digital health & medical technology products and companies