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Roche’s Genentech and Blueprint receive full FDA approval for Gavreto in lung cancer

The targeted therapy was granted accelerated approval for the NSCLC indication in 2020

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FDA approves Taiho’s stronger Lonsurf regimen for metastatic colorectal cancer

The approval comes almost eight years after the regulator approved Lonsurf as a monotherapy for the same indication

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GSK’s Jemperli combination receives FDA approval for endometrial cancer

Approximately 60,000 new cases of endometrial cancer are diagnosed every year in the US

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FDA approves second over-the-counter naloxone nasal spray for opioid overdose

Over 105,000 fatal opioid overdoses were reported in the US between 2022 and 2023

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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

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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

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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

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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

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