Regulation

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.

Junshi receives China’s NMPA acceptance for toripalimab injection

Junshi Biosciences has received acceptance from China’s National Medical Products Administration (NMPA) for toripalimab subcutaneous injection (JS001sc) new drug applications (NDAs) covering 12 indications for cancer treatment.

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).

Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a genetic medicine under investigation for treating Bcl-2-associated athanogene 3 (BAG3)-associated dilated cardiomyopathy (DCM).

Esperion to acquire Corstasis for cardiovascular franchise expansion

Esperion Therapeutics has signed a definitive agreement to acquire Corstasis Therapeutics to expand its cardiovascular franchise with the addition of Enbumyst, a bumetanide nasal spray.

Sanofi receives CHMP recommendation for Dupixent approval in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union (EU) for paediatric patients with chronic spontaneous urticaria (CSU).