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7253 News Found

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.


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


Merck completes acquisition of Prometheus Biosciences
News | June 17, 2023

Merck completes acquisition of Prometheus Biosciences

Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions


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


MoS Health addresses TB Health Technologies workshop
News | June 17, 2023

MoS Health addresses TB Health Technologies workshop

Urges Innovators to produce quality products that can be deployed at scale


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


Bliss GVS Pharma updates on inspection by USFDA
Drug Approval | June 16, 2023

Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection


SMi discloses £6 million seed funding round, bolsters team with new C-suite hire
News | June 15, 2023

SMi discloses £6 million seed funding round, bolsters team with new C-suite hire

Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics


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