The US Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper ...

As many as four out of 10 assessments of new drugs carried out by the Danish Medicines Council had the process stopped midway ...

California-based Tenaya Therapeutics, a biotech seeking to discover, develop and deliver potentially curative therapies that ...

One of the biggest challenges to the cell and gene therapy (CGT) landscape over the last couple of years has been the ...

Results from the PERSEUS Phase III study showed that tolebrutinib did not meet its primary endpoint in delaying time to ...

US biopharma Arcus Biosciences has announced the discontinuation of the Phase III STAR-221 study, being conducted in ...

Swedish rare disease specialist Hansa Biopharma announced a reorganization of its European and International Commercial and ...

Swedish Orphan Biovitrum, also known as Sobi, has entered into a definitive agreement to acquire San Diego, USA-based biotech ...

Japan’s Tanabe Pharma, formerly known as Mitsubishi Tanabe and now owned by Bain Capital, has obtained approval from the ...

On December 12, 2025, the US Food and Drug Administration approved Johnson & Johnson subsidiary Janssen Biotech’s Akeega (niraparib and abiraterone acetate with prednisone for adults with deleterious ...

M&A news last week featured Mirum Pharmaceuticals announcing plans to acquire fellow USA-based Bluejay Therapeutics and its ...

Danish biotech Sidera Bio has raised about 700 million Kroner ($109 million) in a series A financing, one of the largest ...