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Results For "FDA"

2194 News Found

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
Drug Approval | November 22, 2023

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients


GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Drug Approval | November 21, 2023

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024


Teva announces approval of a generic version of Forteo in US
Drug Approval | November 20, 2023

Teva announces approval of a generic version of Forteo in US

This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering


Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India
News | November 17, 2023

Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India

Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain


SMS Pharmaceuticals reports robust Q2FY24 operational performance
News | November 10, 2023

SMS Pharmaceuticals reports robust Q2FY24 operational performance

Q2FY24 EBITDA up by 105% y-o-y at Rs. 28 crore


Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).


The Prostate Cancer Foundation and Bayer announce Bayer – PCF Darolutamide Challenge Awards
News | November 03, 2023

The Prostate Cancer Foundation and Bayer announce Bayer – PCF Darolutamide Challenge Awards

In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer


Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
News | October 30, 2023

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19

The companies plan to start a pivotal Phase 3 trial in the coming months


Innocan Pharma reports discovery regarding its LPD platform and global CBD research
News | October 25, 2023

Innocan Pharma reports discovery regarding its LPD platform and global CBD research

The company expects that this development could improve the strength of its application to the FDA for new drug approval


LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia
Clinical Trials | October 23, 2023

LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia

LG Chem is making progress in the development of the world's first oral treatment for rare forms of obesity.