Shaily gets regulatory nod for launch of ShailyPen Neo device technology

The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market

Bristol Myers Squibb wins EU nod for Sotyktu in active psoriatic arthritis

The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio

ADMA Biologics wins FDA nod to expand ASCENIV use in young children

Revvity tops Q1 estimates and unveils plans to exit China immunodiagnostics

The company also announced a major portfolio shift, planning to divest its Immunodiagnostics business in China, a unit that generated approximately 6% of its fiscal 2025 revenue

OneSource powers second generic semaglutide nod in Canada

Approval marks the second generic semaglutide clearance in Canada and strengthens OneSource’s position in complex injectable CDMO programs

Dr Reddy’s becomes first to secure Health Canada nod for generic Semaglutide injection

Market authorization for generic GLP-1 therapy strengthens company’s diabetes portfolio in Canada

OneSource Pharma, Dr Reddy’s secure Health Canada nod for generic Semaglutide

Approval for generic Semaglutide Injection strengthens CDMO partnership, enabling scalable supply from OneSource’s US FDA-approved Bengaluru facility

AbbVie seeks FDA nod for RINVOQ use in severe alopecia areata

After Phase 3 results show major hair regrowth gains

AbbVie seeks FDA nod for subcutaneous SKYRIZI induction in Crohn’s disease

The submission is backed by positive results from the Phase 3 AFFIRM study