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At a meeting on 5 December 2024, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) approved Zydus’ Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in patients with HER2-positive metastatic and early breast cancer...

On 5 December 2024, Jazz Pharmaceuticals’ announced that Ziihera® (zanidatamab-hrii) 50 mg/mL for injection for intravenous use has been recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A treatment opt...

On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s Tevimbra® (Tislelizumab) for the following indications:

as monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced...

On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of Early Alzheimer’s Disease from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico.

This news follows approval...

On 4 December 2024, Merus announced that the FDA has approved Bizengri® (zenocutuzumab-zbco) for adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that is advanced unresectable or metastatic and has an NRG1 gene fusion.  According to Merus, this is...

On 3 December 2024, MSD, announced that sacituzumab tirumotecan (sac-TMT) has been granted Breakthrough Therapy designation by the FDA for advanced or metastatic NSCLC with epidermal growth factor receptor mutations whose disease progressed on or after tyrosine kinase inhib...

On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab), has been accepted by China’s Center for Drug Evaluation of the National Medical Products Administration.
The indications include: use in co...

On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refrac...

On 3 December 2024, Corbus Pharmaceuticals announced that the US FDA has granted Fast Track designation to CRB-701 (SYS6002) for the treatment of relapsed or refractory metastatic cervical cancer.  CRB-701 (SYS6002) is an antibody drug conjugate targeting Nectin-4 that cont...