Regulation - Approvals

Teva receives FDA approval for Prolia biosimilar

Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA).

Novo Nordisk receives FDA approval for basal insulin Awiqli

Novo Nordisk has secured the US Food and Drug Administration (FDA) approval for Awiqli (insulin icodec-abae) injection 700 units/mL, a basal insulin for adults with type 2 diabetes (T2D).

BMS secures FDA and EC approvals for Opdivo in Hodgkin Lymphoma

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has received approvals for two new indications in classical Hodgkin Lymphoma (cHL) from the US Food and Drug Administration (FDA) and the European Commission (EC), expanding its use for both paediatric and adult patients.

FDA accepts Sun Pharma’s Ilumya sBLA for psoriatic arthritis

The US Food and Drug Administration (FDA) has accepted for review Sun Pharmaceutical’s supplemental biologics licence application (sBLA) submitted for Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis.

Novartis wins FDA approval for Cosentyx to treat paediatric HS patients

Novartis has received the US Food and Drug Administration (FDA) approval for Cosentyx (secukinumab) to treat paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS).

FDA approves GSK’s Wellcovorin for cerebral folate deficiency

The US Food and Drug Administration (FDA) has granted its approval for the expanded use of GSK’s Wellcovorin (leucovorin calcium) tablets to treat cerebral folate deficiency (CFD) in patients with a confirmed variant in the folate receptor one (FOLR1) gene.

Sciwind secures China’s NMPA approval for Ecnoglutide injection

Sciwind Biosciences has received China’s National Medical Products Administration (NMPA) approval for its Ecnoglutide injection for chronic weight management.

BMS gains FDA approval for Sotyktu in psoriatic arthritis treatment

Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Sotyktu (deucravacitinib), an oral selective tyrosine kinase 2 (TYK2) inhibitor, to treat adults with active psoriatic arthritis (PsA).

J&J announces Tecvayli-Darzalex combo approval from FDA for multiple myeloma

Johnson & Johnson (J&J) has announced the US Food and Drug Administration (FDA) approval for the combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma (r/r MM).