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10238 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.


Alkem Laboratories launches awareness initiative
News | June 19, 2023

Alkem Laboratories launches awareness initiative "Stop Sneeze to Wheeze"

Approximately 60 to 78% of individuals diagnosed with Asthma also have concurrent Allergic Rhinitis


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


USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit
News | June 17, 2023

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations


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


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


Ampath expands its footprint in Andhra Pradesh
Healthcare | June 14, 2023

Ampath expands its footprint in Andhra Pradesh

Launched Pathology Laboratory in Vijayawada offering a wide range of best-in-class diagnostic services with over 2500+ tests


Samsung Biologics and Pfizer collaborate for long-term manufacturing of biosimilars portfolio
News | June 14, 2023

Samsung Biologics and Pfizer collaborate for long-term manufacturing of biosimilars portfolio

Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio


Merck gets favourable verdict in patent infringement lawsuit related to Bridion
News | June 14, 2023

Merck gets favourable verdict in patent infringement lawsuit related to Bridion

Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.