pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 billion oral psoriasis therapy Otezla (apremilast).

Labelling 52

Labelling FDA Immunization 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).

Labelling 93

Labelling Immunization FDA 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).

Labelling 93

Labelling Immunization FDA 93

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52