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- PMLiVE

Sarepta Therapeutics

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Biogen/Eisai’s Alzheimer’s disease drug granted full FDA approval

Leqembi was granted accelerated approval earlier this year for patients with early Alzheimer's disease

- PMLiVE

FDA declines to approve Amneal Pharmaceuticals’ Parkinson’s disease treatment

The regulator said the safety for one of the drug's ingredients had not been adequately established

- PMLiVE

FDA approves BioMarin’s Roctavian as first gene therapy for severe haemophilia A

Approximately 2,500 patients are expected to be eligible to receive the one-time therapy

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FDA approves CellTrans’ Lantidra as first cellular therapy to treat type 1 diabetes

The therapy is indicated for use in patients who are unable to meet their target blood glucose levels

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FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine

The decision was supported by interim results from a low dose cohort of the phase 1b/2 ABATE trial

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FDA approves UCB’s Rystiggo to treat generalised myasthenia gravis

The rare autoimmune disease has a global prevalence of 100 to 350 cases per every one million people

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Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Almost 20% of patients with the autoimmune disease are diagnosed before the age of 18

- PMLiVE

FDA grants accelerated approval to Sarepta’s Duchenne muscular dystrophy gene therapy

The disease occurs in up to one in every 5,000 newborn males worldwide

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Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

The approval for the leukaemia drug was supported by additional data from two phase 3 studies

- PMLiVE

Pfizer’s Talzenna combination receives FDA approval for metastatic prostate cancer

Up to 20% of patients develop metastatic prostate cancer within five to seven years of diagnosis

- PMLiVE

bluebird bio’s sickle cell gene therapy accepted for FDA priority review

The genetic disease affects approximately 100,000 people in the US

- PMLiVE

Roche’s fixed-duration lymphoma treatment granted FDA accelerated approval

Globally around 160,000 people are diagnosed with non-Hodgkin's lymphoma each year

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