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- PMLiVE

AstraZeneca and Daiichi Sankyo get FDA approval for breast cancer drug

Results from a phase 3 trial showed Enhertu reduced the risk of disease progression or death by 50%

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Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy

- PMLiVE

FDA approves Coherus’ Cimerli as biosimilar interchangeable with Lucentis for all five indications

Cimerli belongs to the anti-VEGF therapy class of biologics that has helped retinal patients maintain or gain vision

- PMLiVE

Janssen’s Stelara approved by FDA for psoriatic arthritis in paediatric patients

Active psoriatic arthritis affects 5-8% of children and adolescents with chronic inflammatory arthritis

- PMLiVE

Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

Zoryve is the first and only PDE4 inhibitor approved for plaque psoriasis

- PMLiVE

Roche’s Tecentriq demonstrates positive phase 3 results as a subcutaneous injection

Subcutaneously administering Tecentriq reduced the time needed for treatment compared to standard IV infusion

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Regeneron terminates four clinical trials of its COVID-19 antibody cocktail REGEN-COV

The drug was taken off the US market in January due to it being ‘highly unlikely’ to be active against the Omicron variant

- 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

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