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- PMLiVE

CAR-T

regeneron headquarters

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

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

regeneron headquarters

Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

The transaction expands the company’s gene therapy and hearing loss pipeline

- PMLiVE

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

- PMLiVE

NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy

The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

Biogen Idec building

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

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