Abstract
Just like the Internet in 1990’s, Artificial intelligence is now changing all aspects of our life and work. It’s impact is beginning to show in the industry and it is changing the life-sciences practice by fundamentally altering the way how medicines are discovered, developed, manufactured, approved, supplied and brought to market.
In research and discovery, generative models and structure prediction systems shorten the path from target to lead and raise the ceiling…
Shots:
The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK
The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
Shots:
Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.
Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia
Overall, February 2026 reflected…
The Evolution Summit returns May 7-8, 2026 at The Ritz-Carlton, Fort Lauderdale, Florida, bringing together leading clinical trial executives with innovative suppliers and solution providers in an invitation-only, premium setting. Expect visionary keynotes, real-world case studies, and interactive forums aligned to the most pressing challenges in clinical operations and drug development. Featured leaders include…
Shots:
Celltrion has completed the trial for Herzuma SC (CT-P6 SC), a biosimilar version of Herceptin (trastuzumab), and plans to file for marketing approval in the EU and Korea within three months
The trial, which demonstrated PK equivalence to the reference SC formulation, along with comparable safety and immunogenicity, also met its 1EP. Herzuma SC is also expected to enhance patient convenience by reducing administration…
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Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy
Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications
Gazyva is…
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The company has reported dosing of the first patient in the US P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer
BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting
Building…
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FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor
The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
Shots:
Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision
Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
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…

