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Results For "authorization"

327 News Found

AGC Biologics begins operations at new manufacturing building in Copenhagen
News | October 14, 2024

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors


Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun
News | October 02, 2024

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun


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


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


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


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Clinical Trials | 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
Clinical Trials | 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%