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Pfizer and Astellas’ Xtandi granted FDA priority review for new prostate cancer indication

The treatment is already approved in the US for three disease states of prostate cancer

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Pfizer’s maternal RSV vaccine granted FDA approval to protect infants

The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy

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Regeneron’s Veopoz granted FDA approval for ultra-rare immune disease

Fewer than ten patients in the US have been diagnosed with CHAPLE disease

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Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

The drug is the first-ever treatment approved in the US for patients with the disease

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Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

The therapy showed an overall response rate of more than 70% in a broad range of patients

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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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