18/12/2025 BeOne Medicines' BGB-B2033 received the FDA fast track designation for HCC BeOne Medicines' BGB-B2033 received the FDA fast track designation for HCC ( Ref ) The US FDA granted the fast track designation to BeOne Medicines' BGB-B2033 (GPC3 x 4-1BB BsAb) for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment. Julie Lepin, SVP and Chief Regulatory Affairs Officer, BeOne: “ The FDA awards F

December 1st Week, 2025 Regulatory Events 🎯 The US FDA granted approval to  Eli Lilly and Company 's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to  Bristol Myers Squibb 's lisocab

04/12/2025 BMS' Breyanzi received FDA approval for R/R MZL J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC BMS' Breyanzi received FDA approval for R/R MZL ( Ref ) The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy.  The approva

29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 ( Ref ) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on res

August 3rd Week, 2025 Regulatory Events   🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 ( Ref ) Health...

August 2nd Week, 2025 Regulatory Events   🎯 The US FDA granted accelerated approval to  Boehringer Ingelheim 's zongertinib (kinase...

July 2nd Week, 2025 Regulatory Updates   🎯 The EC approved  BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC ( Ref ) The US FDA approved Sirtex Medical's SIR-Spheres...

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma ( Ref )...

June 1st Week, 2025 Regulatory Events 🎯  Takeda  and  Pfizer ’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been...

May 4th Week, 2025 Regulatory Events   🎯 The US FDA granted a Fast Track designation to  CSPC Pharmaceutical Group  ’s CPO301 (SYS6010;...

April 3rd Week, 2025 Regulatory Events   🎯  Bristol Myers Squibb ’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved...

March 1st Week, 2025 Regulatory Events 🎯  Bristol Myers Squibb ’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by...

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met...