Regulation

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).

BioMarin receives FDA approval for Palynziq use in adolescents

BioMarin Pharmaceutical has received the US Food and Drug Administration (FDA) approval for its supplemental biologics licence application (sBLA) for Palynziq’s (pegvaliase-pqpz) use in adolescents aged 12 and above with phenylketonuria (PKU).

FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease

Beren Therapeutics has received the US Food and Drug Administration (FDA) acceptance to review its New Drug Application (NDA) for adrabetadex, an investigational therapy targeting intracellular cholesterol trafficking for infantile-onset Niemann-Pick disease type C (NPC).

AstraZeneca’s Calquence plus venetoclax gains approval in US to treat CLL

AstraZeneca has secured approval in the US for Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen to treat adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the first-line setting.