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Results For "marketing-authorization"

155 News Found

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco
News | October 01, 2024

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco

The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia


Lupin signs distribution agreement with Celnova for orphan drug NaMuscla
Supply Chain | September 28, 2024

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


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


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Diagnostic Center | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure
Diagnostic Center | September 02, 2024

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure

Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%


Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Diagnostic Center | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study
Diagnostic Center | August 05, 2024

Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study

Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy