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. However, he did note that Stelara does have a composition of matter patent expiry in mid-2024 in Europe.

Food and Drug Administration 87

Food and Drug Administration FDA Side effects Safety 87

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.

Food and Drug Administration 93

Food and Drug Administration Side effects Safety Food 93

pharmaphorum

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. billion respectively last year.

FDA 52

FDA Side effects Prospecting Patients 52

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.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

Pharmaceutical Technology

JUNE 16, 2023

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. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

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].

Food and Drug Administration 93

Food and Drug Administration Side effects Leads Patients 93

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].

Food and Drug Administration 92

Food and Drug Administration Side effects Leads Patients 92