The FDA has approved GSK's gepotidacin, the first oral antibiotic to offer a new mechanism of action in uncomplicated urinary tract infections (uUTIs) in nearly 30 years, after a priority review.

MoonLake Immunotherapeutics has secured up to $500 million in non-dilutive financing from Hercules Capital, bolstering its cash reserves as it ushers its lead drug for inflammatory diseases ...

While it sends some signals about the priorities of new FDA Commissioner Dr Martin Makary, the actual impact of the directive ...

GSK's Blenrep (belantamab mafodotin) has officially been approved by the UK's Medicines and Healthcare products Regulatory ...

An international agreement on pandemic preparedness is finally complete after three years of negotiation. The World Health ...

Merida Biosciences has emerged from Third Rock Ventures with $121 million in first-round financing for a pipeline of drugs ...

This new approach to lab space is emblematic of a broader trend in real estate: the conversion of under-utilised office space ...

Pursue advocacy efforts We’ve seen critical legal decisions over the last five years either accelerate or stymie the United States biosimilar market. In the 2017 Amgen v. Sandoz case, the ...

AstraZeneca has revealed phase 2b results with its oral PCSK9 inhibitor AZD0780, including a more than 50% reduction in LDL-cholesterol when added to standard therapy, as it tries to narrow a lead ...

Vertex Pharma's non-opioid painkiller suzetrigine was unable to perform better than placebo in a phase 2 trial in lumbosacral radiculopathy (LSR), a form of neuropathic back pain, ahead of an FDA ...

The EMA's human medicines committee has said it does not recommend approval of Eli Lilly's anti-amyloid Alzheimer's disease treatment Kisunla, saying its modest benefits don't outweigh its risks.

CSL Behring has added another major European market to the list of those providing reimbursement coverage of its haemophilia B gene therapy Hemgenix, after agreeing an access deal in Germany.