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FDA issues approval for Sanofi’s Enjaymo treatment for patients with CAD

The treatment is the first-of-its-kind for patients living with cold agglutinin disease, a rare blood disorder

- PMLiVE

Celltrion submits application for inhaled COVID-19 antibody treatment

A global phase 3 clinical study will evaluate the inhaled antibody cocktail treatment for patients with mild-to-moderate COVID-19 symptoms

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Six million patients affected by delay to NHS England’s plans to address COVID-19 backlog

UK’s health and social care secretary Sajid Javid said that the number of patients on these hospital waiting lists would increase before beginning to fall

- PMLiVE

MHRA issues CMA for Novavax COVID-19 vaccine

Nuvaxovid offers up to 89% protection against COVID-19

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New Omicron subvariant appears more transmissible but no more severe than original Omicron strain

The new subvariant is already emerging as a dominant strain in Denmark, the Philippines, Nepal, Qatar and India

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FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

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Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

- PMLiVE

Moderna begins phase 2 trial of Omicron-specific booster

The study will include two groups, with approximately 300 people in each group

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FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

- PMLiVE

Pfizer and BioNTech start clinical trial for Omicron-based COVID-19 vaccine

The clinical trial involves adults aged 18 to 55 who received an Omicron-based vaccine candidate as part of a two-dose primary series, as well as a booster

- PMLiVE

FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

- PMLiVE

FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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