Oncology
Genmab receives EC approval for lymphoma therapy
Genmab has received conditional marketing authorisation from the European Commission (EC) for TEPKINLY (epcoritamab) as a monotherapy to treat adults…
Novartis eyes first-line status for its radionucleotide therapy Lutathera
Novartis has announced that the Phase III NETTER-2 trial of the combination therapy of Lutathera (lutetium Lu 177 dotatate) and…
China’s NMPA approves Henlius’ oesophageal cancer therapy
China’s National Medical Products Administration (NMPA) has granted approval for Shanghai-based Henlius Biotech’s Hansizhuang (serplulimab injection) for use in PD-L1…
Merck and ICR enter renewed cancer drug discovery partnership
Merck KGaA (Merck) and the UK's Institute of Cancer Research (ICR) have entered a renewed strategic collaboration to discover and develop new…
JURA Bio and Syena partner to develop TCR-based therapies
JURA Bio has entered a research collaboration with Replay cell therapy product company Syena for the development of T cell…
GSK’s Ojjaara receives FDA approval for treating myelofibrosis patients with anaemia
On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib),…
EC grants approval for Menarini’s breast cancer therapy
The European Commission (EC) has granted approval for the Menarini Group’s Orserdu (elacestrant) to treat patients with estrogen receptor (ER)‑positive, HER2-negative,…
BeiGene agrees with Novartis for global rights to TEVIMBRA
BeiGene has signed an agreement with Novartis to regain global rights related to the humanised IgG4 anti-PD-1 antibody, TEVIMBRA (tislelizumab).…
FDA grants priority review for Merck’s sNDA of renal cancer therapy
The US Food and Drug Administration (FDA) has accepted supplemental new drug application (sNDA) of Merck’s (MSD) Welireg for advanced renal cell…
Sandoz receives EMA CHMP approval for Herceptin biosimilar
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Sandoz’s Herceptin (trastuzumab)…