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- PMLiVE

severe hypertriglyceridemia

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AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

- 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

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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

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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

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Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines

The study informs policymakers about the optimal deployment of COVID-19 vaccines over the next 12 months

- 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

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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

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AstraZeneca acquires TeneoTwo in a deal worth up to $1.27bn

The acquisition includes TeneoTwo’s phase 1 clinical-stage T-cell engager

- PMLiVE

Pfizer and BioNTech sign $3.2bn COVID-19 vaccine supply agreement with US government

The companies will supply 105 million doses, which may include adult Omicron-adapted COVID-19 vaccines, subject to FDA authorisation

- PMLiVE

FDA issues innovative proposal to increase nonprescription drug access

Nonprescription drugs provide an efficient, low-cost way to manage everyday health needs and include drugs for allergies, pain, fever and many more indications

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