Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)

AbbVie receives positive CHMP opinion for Risankizumab for treatment ulcerative colitis

Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine

Modular ATP study of the mCRM System meets primary safety and efficacy endpoints

Additional data from APPRAISE ATP trial reinforce modular therapy approach

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease

CuraTeQ Biologics announces the successful Phase 1 clinical study outcome of their BP11 product

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America

AbbVie launches Produodopa for treatment of parkinson's disease in EU

Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations