Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib for the first-line treatment of individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).
Santhera Pharmaceuticals has reported that the China National Medical Products Administration (NMPA) granted priority review for a new drug application (NDA) for vamorolone, for Duchenne muscular dystrophy (DMD).
Clinical stage biotechnology company Q32 Bio has announced the conclusion of its merger with Homology Medicines, for an undisclosed sum.
Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.
Evommune has announced an expanded strategic partnership with Maruho for the development and commercialisation of EVO756 in Greater China and some Asian countries.
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.
Tubulis has secured €128m ($138.8m) in a Series B2 financing round to expedite the clinical development of its antibody drug conjugates (ADCs) pipeline, focused on solid tumours.
The US Food and Drug Administration (FDA) has granted approval for Novo Nordisk's Wegovy (semaglutide 2.4 mg) for lowering cardiovascular risks in adults with established cardiovascular disease (CVD) who are overweight or obese.
iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic cancer.
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