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Results For "FDA"

2298 News Found

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.


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.


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


Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Drug Approval | June 16, 2023

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA


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


Airnov to showcase HDPE bottle range at upcoming CPHI China
News | June 15, 2023

Airnov to showcase HDPE bottle range at upcoming CPHI China

The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications


Granules India receives ANDA approval for Levetiracetam Tablets
Drug Approval | June 15, 2023

Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA


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.


Pfizer and GSK to battle for share of new RSV vaccine market, says GlobalData
News | June 13, 2023

Pfizer and GSK to battle for share of new RSV vaccine market, says GlobalData

Pfizer is likely to show GSK significant competition


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