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Results For "clinical-data"

188 News Found

Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr
News | February 17, 2025

Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr

Glenmark’s consolidated revenue was at Rs. 3,387.6 crore as against Rs. 2,506.7 crore recording an increase of 35.1% YoY


Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia
Drug Approval | December 27, 2024

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia

GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH


Ikena Oncology and Inmagene Biopharmaceuticals announce agreement for merger
News | December 24, 2024

Ikena Oncology and Inmagene Biopharmaceuticals announce agreement for merger

The transaction is expected to result in approximately $175 million to support further development of IMG-007


FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test
News | October 21, 2024

Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test

Financing includes new funding from leading global organizations Eli Lilly and Company and EDBI


AstraZeneca advances science of infectious disease protection at IDWeek 2024
News | October 18, 2024

AstraZeneca advances science of infectious disease protection at IDWeek 2024

Data demonstrate the importance of protecting against serious respiratory infections caused by respiratory syncytial virus, human metapneumovirus and COVID-19


Pfizer withdraws all lots of sickle cell disease treatment voxelotor
News | September 26, 2024

Pfizer withdraws all lots of sickle cell disease treatment voxelotor

Pfizer's decision is based on the totality of clinical data


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine
Drug Approval | August 23, 2024

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older