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Dec 6, 2024
In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns. In a response made available on 26 November 2024, the US Alliance for Pharmacy...
Dec 6, 2024
On 6 December 2024, AstraZeneca announced that its sBLA for Imfinzi® (durvalumab) has been granted Priority Review by the US FDA for the treatment of patients with muscle-invasive bladder cancer (MIBC). This follows AstraZeneca’s announcement in August 2024 that the...
Dec 5, 2024
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
Dec 5, 2024
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...
Dec 5, 2024
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 or...
Dec 5, 2024
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...
Dec 4, 2024
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,...
Dec 4, 2024
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...
Dec 4, 2024
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...
Dec 4, 2024
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...
Dec 3, 2024
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...
Dec 2, 2024
On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab). Yesintek® joins five other previously FDA-approved Stelara® biosimilars: Formycon and Fresenius Kabi’s Otulfi®...
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