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6837 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.


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


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


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


Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines
News | June 19, 2023

Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines

Despite nearly 20 years of availability, biosimilars show worldwide adoption rate of only 14% in initiative-tracked countries, while reference medicines still represent 86% of biologic


Nanoform and Celanese demonstrate enhanced drug delivery through smaller implants
News | June 19, 2023

Nanoform and Celanese demonstrate enhanced drug delivery through smaller implants

The increased drug load enabled by the nanoformed particles also allows smaller implants with sustained release properties to be developed.


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