Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Shots: The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab) BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…

ByDipanshu DixitJanuary 13, 2026

NEWS

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…

ByRidhi RastogiSeptember 16, 2025

NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…

ByRidhi RastogiSeptember 15, 2025

TOP 20

Top 20 Oncology Companies of 2025

Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

ByPrince GiriSeptember 3, 2025

NEWS

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Shots: The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC) Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC Additionally, Anbogen is pursuing global licensing,…

ByRidhi RastogiAugust 4, 2025

NEWS

Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Shots: Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643) Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…

ByRidhi RastogiMay 15, 2025

NEWS

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

Shots: The US FDA has approved Jobevne, a biosimilar version of Avastin (bevacizumab) for IV administration Approval was based on extensive data showing Jobevne is similar to Avastin in PK, safety, efficacy, structure, & function across clinical & analytical studies Jobevne (VEGF inhibitor) is marketed under the brand name Abevmy in the EU & Canada,…

ByRidhi RastogiApril 10, 2025

NEWS

Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications

Shots: The EMA has granted approval to the company’s Avzivi (bevacizumab), a biosimilar version of Avastin. Sandoz is responsible for marketing the drug across the EU The license and commercialization agreement b/w Bio-Thera and Sandoz was signed in Sep 2021, under which Bio-Thera had the development and manufacturing rights while Sandoz secured the commercialization…

ByDipanshu DixitJuly 30, 2024

TOP 20

Top 20 Monoclonal Antibodies Based on 2022 Total Revenue

Shots: Monoclonal antibodies are transforming therapeutics through their highly efficient targeting mechanisms. There is a wide range of uses for monoclonal antibodies, including diagnosis, therapy, and research In 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Humira was the…

ByPrince GiriSeptember 26, 2023

TOP 20

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology- cardiology- and neurology but are they…

ByPrince GiriJuly 17, 2020

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Top 20 Oncology Companies of 2025

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications

Top 20 Monoclonal Antibodies Based on 2022 Total Revenue

Top 20 Prescription Drugs Based on 2019 Revenue

Contact US

FOLLOW US