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Results For "approval"

2477 News Found

Lupin launches Mirabegron ER tablets in US
Drug Approval | September 04, 2024

Lupin launches Mirabegron ER tablets in US

Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development


Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Vaishali Pharma Ltd recommends 1:1 bonus issue and 1:5 stock split
News | August 30, 2024

Vaishali Pharma Ltd recommends 1:1 bonus issue and 1:5 stock split

The company is making its mark through strategic initiatives, promising to become a significant presence in the evolving pharmaceutical sector


EC approves Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
Drug Approval | August 27, 2024

EC approves Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma

Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Fasenra approved in China for the treatment of severe eosinophilic asthma
Drug Approval | August 25, 2024

Fasenra approved in China for the treatment of severe eosinophilic asthma

Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control


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


Balancing wellness and waste: sustainable solutions for medical packaging: MHolland
Packaging | August 22, 2024

Balancing wellness and waste: sustainable solutions for medical packaging: MHolland

Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices


Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine