SteQeyma™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, ...

INCHEON, South Korea, December 18, 2025--(BUSINESS WIRE)--Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...

Please provide your email address to receive an email when new articles are posted on . Feasibility and acceptability scores for the autoinjector were highest among health care professionals. All ...

A Prescription Drug User Fee Act target date of July 26, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application ...

(RTTNews) - MannKind Corp.'s (MNKD) supplemental new drug application of FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with chronic heart failure or chronic kidney disease has ...

On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly ...

SteQeyma ™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, ...

MannKind Corporation delivered strong Q3 '25 results, beating EPS and revenue estimates, and shares have responded positively. The FDA accepted the supplemental New Drug Application for the FUROSCIX ...

Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a ...

Pyzchiva® first ustekinumab biosimilar in Europe commercially available in pre-filled pen (autoinjector), offering improved self-administration experience for better treatment adherence and quality of ...