Breaking

MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●

Biocon Pertuzumab Biosimilar Pebrilzo Wins CHMP Opinion

Biocon's pertuzumab biosimilar Pebrilzo has received a positive CHMP opinion — the first monoclonal antibody biosimilar under the EMA's tailored clinical development approach for HER2-positive breast cancer.

Dr. Eleanor Vance, Regulatory Affairs Editor|28 September 2026|6 min read

Treatments

FDA Approves Imlunestrant Combination for ESR1 Breast Cancer

The FDA has fully approved imlunestrant plus abemaciclib for ESR1-mutated ER-positive breast cancer, with EMBER-3 showing 11.1 vs 5.5 months PFS. Read on.

Tom Okafor, Clinical Trials Correspondent·24 September 2026·3 min read

FDA Clears Finerenone for Type 1 Diabetes Kidney Disease

A 242-patient trial with a urinary biomarker endpoint has carried finerenone into a new US indication. The number that matters is not the 25% in the headlines, and no UK or EU decision for type 1 diabetes has been reported.

Tom Okafor, Clinical Trials Correspondent·21 September 2026·8 min read

OS Therapies Project Orbis MHRA Osteosarcoma Signal

MHRA asked OS Therapies to bring OST-HER2 into Project Orbis and accepted literature-derived historical controls in resected metastatic osteosarcoma. The procedural precedent matters more than the candidate, and every load-bearing fact is the sponsor's.

Dr. Eleanor Vance, Regulatory Affairs Editor·21 September 2026·8 min read

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Research

What the evidence shows about BPC-157 and tendons

More than 100 animal studies suggest BPC-157 helps tendons heal, yet as of 2026 not a single controlled human trial has tested whether it works in people. A US advisory panel has voted to loosen access all the same.

Tom Okafor, Clinical Trials Correspondent·9 September 2026·8 min read