European Pharmaceutical Review

DECEMBER 22, 2023

It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. US sales of Stelara totalled $6.4 billion in 2022, according to J&J’s financial results.

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Pharmaceutical Technology

APRIL 21, 2023

It will pay another $10m in instalments through to September 2024. Entadfi, a combination of finasteride and tadalafil, is administered as an oral, once-a-day drug to provide a safe and effective treatment option for benign prostatic hyperplasia (BPH), often referred to as enlarged prostate, in men.

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Pharmaceutical Technology

JUNE 16, 2023

While the drug is marketed in other countries, it is not registered in the US. But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects.

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

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