Approvals

MediLink and Roche announce exclusive licensing agreement for YL201c

MediLink Therapeutics has signed an exclusive licensing agreement with Roche for the development and commercialisation of YL201, an investigational antibody-drug conjugate (ADC) targeting B7H3 in various solid tumour types.

Octapharma receives FDA approval for new Fibryga formulation in AFD

Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga for use in patients with acquired fibrinogen deficiency (AFD).

Zai Lab’s Augtyro receives NMPA approval for solid tumours in China

Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Takeda and Protagonist seek FDA approval for rusfertide to treat PV

Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV).

Arrowhead receives Health Canada authorisation for Redemplo to treat FCS

Arrowhead Pharmaceuticals has received authorisation from Health Canada for its small interfering RNA (siRNA) medicine, Redemplo (plozasiran), as an adjunct to diet for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS) who have not responded to standard therapies.

Genentech secures FDA approval for Lunsumio VELO SC for follicular lymphoma

Genentech, a subsidiary of the Roche Group, has received the US Food and Drug Administration’s (FDA) accelerated approval for Lunsumio VELO subcutaneous (SC) formulation to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

Cytokinetics receives FDA approval for MYQORZO tablets for oHCM

Cytokinetics has announced that the US Food and Drug Administration (FDA) has approved MYQORZO (aficamten) tablets in 5mg, 10mg, 15mg, and 20mg doses for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to enhance functional capacity and symptoms.

Boehringer’s Jascayd gains China’s NMPA approval for PPF

China’s National Medical Products Administration (NMPA) has granted approval for Boehringer Ingelheim’s Jascayd (nerandomilast) to treat progressive pulmonary fibrosis (PPF).

Health Canada approves Biogen’s Zurzuvae for PPD treatment

Biogen has received a notice of compliance (NOC) from Health Canada for Zurzuvae (zuranolone), a neuroactive steroid (NAS), as a treatment for moderate or severe postpartum depression (PPD) in women.