In the Phase III HARMONi-6 trial, ivonescimab plus chemotherapy significantly outperformed tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer.

Results from the dual Phase III TRIUMpH trials demonstrated the statistical superiority of tegoprazan over lansoprazole in patients with erosive esophagitis and non-erosive reflux disease.

CMS’ draft guidance on real-world data study protocols marks a significant move toward transparency and rigor in Medicare coverage decisions.

The lawsuit filings are the latest turn in a long-running legal saga between GLP-1RAs makers and compounders.

Veraxa Biotech will gain access to $253m in cash from Voyager to advance its cancer drug pipeline.

In the Phase III ARISE trial, Cobenfy administered as an adjunctive treatment to atypical antipsychotics for patients with inadequately controlled schizophrenia did not achieve statistically significant improvements.

The startup, Veraxa, has $253 million in cash and is raising a crossover funding round to support a pipeline of T cell engagers and bispecific drugs for cancer. 

Contraception for women has seen little change over the past 50 years, with the most prevalent contraceptive pills containing synthetic hormones.

EditCo Bio has entered a licensing agreement to secure access to Promega’s protein-tagging and bioluminescent identification technologies.

A late-stage study found Cobenfy wasn’t better than a placebo as an add-on to atypical antipsychotics. Some analysts view the failure as a “significant hit” to the drug’s commercial outlook.

The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug developers.

Repertoire Immune Medicines will get $35 million upfront, and possibly $730 million more, in a deal to help Roche’s Genentech division unearth T-cell targeting therapies for inflammatory diseases.  

The agreement gives Boehringer access to Tessellate’s novel approach targeting ALT-dependent tumours.

ConcertAI has announced an agreement with Bayer that allows the latter to utilise its Translational360 and AI SaaS solutions.

Arda Ural explains how the tariffs will impact profit margins and potentially cause drug shortages.

TNF and Renova Health are set to use AI and ML for the identification of high-risk subjects who could benefit from GLP-1 therapies

Results from the Phase IIb SunRISe-1 study demonstrated a one-year duration of response with the TAR-200 intravesical gemcitabine-releasing system in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

With combined investments exceeding $53 billion, both companies are deepening their US presence through expanded biologics production, gene therapy capabilities, and next generation R&D centers.

In April 2025, the EU announced details about the first two medicinal products to undergo joint clinical assessments (JCAs).