On August 29, 2023, AbbVie submitted a new indication application to the US FDA and European EMA for Skyrizi (Risankizumab) for the treatment of moderate to severe ulcerative colitis (UC) in adults.
Merck announced that Merck announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score≥1).
TScan Therapeutics, Inc.announced today that the U.S. FDA has given approval for its new experimental drug TSC-203-A0201, a TCR-T pinpointing PReferentially expressed Antigen in Melanoma.
SparingVision has shared encouraging early safety data from the Phase I/II clinical trial of its primary gene-agnostic gene therapy, SPVN06, designed to treat retinitis pigmentosa.
Janssen has filed an additional Biologics License Application with the U.S. Food and Drug Administration, seeking endorsement for RYBREVANT® (amivantamab-vmjw) to be combined with Chemotherapy.
The inaugural patient has been administered with ATSN-201 under the Phase I/II Clinical Trial, for combatting X-linked Retinoschisis, as announced by Atsena Therapeutics.
The U.S. FDA has sanctioned the use of Bristol Myers Squibb's Reblozyl® (luspatercept-aamt) as an initial treatment option for anemia in adults suffering from low-risk Myelodysplastic Syndromes (MDS) who might need transfusions.
Formycon has publicized that its biosimilar candidate FYB203, a potential replica of Eylea® (aflibercept), has been approved for filing by the U.S. Food and Drug Administration (FDA).
The investigational cell treatment, bemdaneprocel (BRT-DA01), showed good tolerance and no major safety concerns throughout a year in 12 subjects belonging to both low and high dose groups.