Australia’s Therapeutic Goods Administration (TGA) has accepted a court-enforceable undertaking from Your Solution ...

A key result of recent European workshops is that drug studies should be designed in such a way that they address both ...

Danish patients with serious illnesses are increasingly gaining access to advanced therapy medicinal products (ATMPs). This ...

Japanese ophthalmology company Santen Pharmaceutical (TYO: 4536) said it has earned approval from Chinese regulatory, the ...

In the news last week, US Center for Biologics Evaluation and Research (CBER) Dr Peter Marks quit his post after reported ...

April 4, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost ...

The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Wainzua (eplontersen) to treat adults with ...

Swedish biotech OncoZenge (Nasdaq: ONCOZ) has expanded its regulatory team as it prepares for a Phase III trial of BupiZenge ...

The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' ...

Struggling US genomic medicines company Sangamo Therapeutics (Nasdaq: SGMO) has been offered a lifeline via a licensing deal ...

German tech conglomerate Siemens has signed an agreement with Miko Pharma to develop facilities for the local production of ...