Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

aflibercept

- PMLiVE

Sarepta to submit application for Duchenne muscular dystrophy gene therapy

The condition occurs in approximately one in every 3,500-5,000 newborn males worldwide

- PMLiVE

FDA grants priority review to Biogen’s tofersen for genetic form of ALS

The approval follows a failed phase 3 study, but the treatment showed promise in patients with SOD1-ALS

- PMLiVE

Roche’s Vabysmo recommended for EU approval by CHMP for sight loss

If approved, Vabysmo would be the first mechanism of action for nAMD and DME in the EU for over ten years

- PMLiVE

Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

- PMLiVE

FDA approves Incyte’s Opzelura for vitiligo

It is the first and only FDA-approved product for repigmentation in patients with nonsegmental vitiligo

- PMLiVE

Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation

Alzheimer's affects more than 55 million people globally and is the most common form of dementia

- PMLiVE

Roche announces two-year data confirming Vabysmo improves neovascular age-related macular degeneration

The data showed, after two years, that 60% of patients treated with Vabysmo could be treated every four months, compared with 45% in year one

- PMLiVE

Sanofi and Regeneron announce positive phase 3 trial results for eosinophilic oesophagi in children under 12

There are currently no approved treatments for children with eosinophilic oesophagi under the age of 12

- PMLiVE

FDA grants Novavax’s COVID-19 vaccine emergency use authorisation for adults

The decision was based on data from a phase 3 trial which showed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19

- PMLiVE

Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma

If approved, this could be the first such antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma

- PMLiVE

Pfizer’s Paxlovid given FDA permission to be prescribed by US pharmacists

Under the Emergency Use Authorisation revision, pharmacists will be able to prescribe the COVID-19 treatment to patients, providing they meet certain conditions

- PMLiVE

FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease

Lecanmab is being evaluated in the ongoing phase 3 Clarity Alzheimer's clinical trial

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links