Respiratory

FDA grants fast track status to Zai Lab’s lung cancer treatment

The US Food and Drug Administration (FDA) has granted fast track designation to Zai Lab’s delta-like ligand (DLL3) antibody-drug conjugate (ADC), ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC).

Apnimed acquires rights to sleep apnoea treatment from Desitin Arzneimittel

Apnimed has acquired the intellectual property and exclusive worldwide rights from European pharma company Desitin Arzneimittel for developing and commercialising a differentiated carbonic anhydrase inhibitor, sulthiame, targeting sleep apnoea and sleep-related breathing conditions.

Japan’s MHLW authorises Regeneron and Sanofi’s Dupixent for COPD

The Ministry of Health, Labour and Welfare (MHLW) in Japan has authorised Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating chronic obstructive pulmonary disease (COPD) in adults.

UK MHRA approves Vertex’s Alyftrek for cystic fibrosis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.

FDA grants priority review to Dizal’s sunvozertinib NDA for NSCLC treatment

The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.

China’s NMPA approves Innovent’s taletrectinib for NSCLC treatment

China's National Medical Products Administration (NMPA) has granted approval to the second new drug application (NDA) of Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI), DOVBLERON (taletrectinib adipate capsule) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Dyadic receives grant from Gates Foundation for RSV antibody development

Dyadic International has received a $3m grant from the Bill & Melinda Gates Foundation to develop monoclonal antibodies (mAbs) for the treatment of respiratory syncytial virus (RSV) and malaria.

AstraZeneca and Daiichi Sankyo submit BLA to FDA for lung cancer treatment

AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).

FDA approves Verona Pharma’s Ohtuvayre for COPD treatment

The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.