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8440 News Found

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


HearClear partners with Neuberg Diagnostics to create integrated hearing care ecosystem
Healthcare | August 23, 2024

HearClear partners with Neuberg Diagnostics to create integrated hearing care ecosystem

The brand will establish an integrated hearing care ecosystem at Neuberg Diagnostics centers across the length and breadth of the country


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


Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg
Drug Approval | August 21, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India


Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program
News | August 21, 2024

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


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


Health Minister Nadda reviews Monkeypox situation and preparedness
Policy | August 19, 2024

Health Minister Nadda reviews Monkeypox situation and preparedness

Monkeypox infections are usually self-limiting lasting between 2-4 weeks and patients generally recover with supportive management