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3046 News Found

DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine
News | June 21, 2023

DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine

The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield


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


Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets
Drug Approval | June 20, 2023

Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets

The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.


USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
Drug Approval | June 19, 2023

USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma


Astellas and Cullgen enter inks agreement to advance innovative targeted protein degraders
News | June 19, 2023

Astellas and Cullgen enter inks agreement to advance innovative targeted protein degraders

Cullgen will have the option during the initial stages of clinical development to participate equally in the costs, profits and losses


Laurus Labs signs MOA with IIT Kanpur for novel gene therapy assets
Biotech | June 19, 2023

Laurus Labs signs MOA with IIT Kanpur for novel gene therapy assets

Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets


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


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