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●

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

Pharmaceutical

The AI revolution in drug discovery, predicting efficacy and compressing R&D timelines

Rising costs and stagnating productivity define the drug development problem that Eroom’s Law describes. The inflation-adjusted cost of bringing a new medicine to market has roughly doubled every 9 years since the 1980s, despite advances in screening and molecular biology. The…

Megan Liu, Digital Health Reporter·11 September 2026·12 min read

Latest Research & Insights

Expert analysis from pharmaceutical industry leaders

View All Articles→

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