AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results
Find out why FDA’s complete response letter for Corcept’s relacorilant could reshape treatment of hypercortisolism, with implications for oncology approval.
For much of the past two decades, monoclonal antibodies have dominated modern drug development. Their ability to bind with high specificity, block protein function, and engage immune mechanisms has transformed the treatment of cancer, autoimmune disorders, and infectious disease. But despite their blockbuster status, biologics have a blind spot. They are largely excluded from the
In the decades-long war against disease, pharmaceutical companies have learned to build drugs like locksmiths—designing compounds that fit neatly into molecular pockets, disabling enzymes and receptors with surgical precision. But not every biological lock comes with a keyhole. Protein–protein interactions, or PPIs, often involve broad, flat, and shifting surfaces that refuse to conform to conventional
For decades, pharmaceutical pipelines have danced around one of biology’s most powerful but untouchable entities: transcription factors. These master regulators control gene expression and orchestrate cellular behavior, yet their structure and function have kept them out of reach for small molecule therapeutics. Unlike enzymes or receptors, transcription factors operate deep within the cell nucleus, often
Find out how Jacobio Pharma’s global licensing deal with AstraZeneca could reshape KRAS‑targeted cancer therapy development.
PRISM BioLab and Talus Bio aim to drug the undruggable with AI–PPI chemistry. Find out how this platform could transform transcription factor drug discovery.
Harbour BioMed has signed a global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multispecific antibodies. The deal could be worth over $1.1 billion across upfront payments, milestones, and royalties. It also signals growing interest in platforms capable of generating novel immunotherapies for complex diseases. The announcement is not
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (trastuzumab deruxtecan), in combination with pertuzumab, has received U.S. Food and Drug Administration approval as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer, based on results from the DESTINY-Breast09 Phase III trial. The approval marks the first new frontline treatment in over a decade
Avenzo shares Phase 1 data on CDK2 inhibitor AVZO-021 in HR+/HER2- breast cancer. Find out what it means for post-CDK4/6 resistance strategies in 2025.