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The FDA approved Eli Lilly’s Zepbound™ (Tirzepatide) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a specified initial body mass index (BMI).  Tirzepatide is a glucose-dependent insulinotropic polypeptid...

Takeda announced that the US Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib) for the oral treatment of adults with Metastatic Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemot...

Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab).  The sBLA ...

The Korea Economic Daily reported that Celltrion announced record quarterly earnings, with an operating profit of ₩276.6 billion, an increase of 25.2% the same period in 2022, and estimated profit and revenue respectively of ₩220 billion and ₩620 billion.  Celltrion’s key m...

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in c...

A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support mAbxience’s MB02 bioequivalence to Genentech’s Avastin® (bevacizumab) (EU and US).  No clinically meaningful differences in safety or immunogenicity were obser...

Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU.  Tyenne® was approved by the EC on 19 September 2023 to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis...

MSD announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.  This brings the total number of US approved gastro...