Pharma News

The FDA has expanded its approval of Seagen’s Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide to treat pediatric patients t...

The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutation...

Satsuma Pharmaceuticals’ STS101 (dihydroergotamine nasal powder) did not pass muster in a phase 3 clinical trial for treatment of acute migraine.

Officials with the FDA have accepted a New Drug Application (NDA) for zilucoplan, a peptide inhibitor of complement component 5 (C5 inhibitor), for the treatment of generalized myasthenia gravis in...

EQRx Therapeutics is dropping its U.S. developmental efforts for sugemalimab plus chemotherapy, a combination it was working on as a treatment for stage IV nonsmall cell lung cancer (NSCLC). ...

The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with stage 4 nonsmall-cell lung cancer ...

The European Commission has granted a marketing authorization to Stada and Xbrane’s Ximluci (ranibizumab), a biosimilar of Novartis’ Lucentis (ranibizumab), to treat retinal vascular disorders....

Royalty Pharma has purchased a royalty interest in Amgen’s small interfering ribonucleic acid (siRNA) therapy, olpasiran, from Arrowhead Pharmaceuticals for an upfront payment of $250m in cash. ...

A federal jury in Massachusetts has decided that Eli Lilly must pay Teva Pharmaceuticals approximately $176.5 million in damages over infringement of three patents covering Teva’s migraine treat...

The FDA has granted Sobi’s Kineret (anakinra) Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk o...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said it will allow the interchangeability of biosimilars, in a final guidance that adopts a similar approach to that taken earl...

One day soon, including pharmacogenomics testing for all patients will be essential for precise prescribing.