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- PMLiVE

Janssen receives positive CHMP opinion for Talvey in multiple myeloma

More than 50,900 people in Europe were diagnosed with multiple myeloma in 2020

- PMLiVE

Sandoz granted positive CHMP opinion for multiple sclerosis biosimilar

The neurological disease affects approximately 2.8 million people worldwide

- PMLiVE

Gilead’s COVID-19 treatment approved by FDA for patients with severe renal impairment

Use of Veklury among this patient population has previously been limited

- PMLiVE

Novavax’s COVID-19 vaccine granted full marketing authorisation in EU

The EC’s decision was supported by positive results from a phase 3 trial evaluating Nuvaxovid

- PMLiVE

FDA advisory committee backs updated COVID-19 vaccines targeting XBB variants

The XBB.1.5 variant accounted for nearly 40% of all US COVID-19 cases as of early June

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EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The EU regulator concluded that the benefits of Adakveo did not outweigh its risks

- PMLiVE

COVID-19: Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s oral antiviral was granted accelerated approval in the US in December 2021

- PMLiVE

Novavax announces positive phase 2 results for COVID-19/influenza vaccine candidates

A combination COVID-19/influenza vaccine is included in the mid-stage study

- PMLiVE

WHO declares end to COVID-19 global public health emergency

The agency’s emergency committee said it is time to transition to long-term management of the pandemic

- PMLiVE

GSK’s RSV vaccine candidate recommended by CHMP for older adults

RSV infections in older adults account for over 270,000 hospitalisations each year in Europe

- PMLiVE

WHO announces launch of new pandemic preparedness initiative

The guidance focuses on respiratory pathogens, including influenza and RSV

- PMLiVE

Novartis’ Cosentyx recommended by CHMP for hidradenitis suppurativa

An estimated one in 100 people globally are affected by the inflammatory skin disease

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