Regulatory
Friday’s European Commission approval is a boost to AbbVie as the company looks to lean on its immunology assets, including Skyrizi, to soften the blow of Humira’s loss of exclusivity.
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
Fatalities are an unfortunate reality of clinical trials. How can companies best protect themselves?
After more than a decade devoid of therapeutic advancements, a first-in-class T cell receptor therapy could be on the immediate horizon for synovial sarcoma patients.
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment.
The FDA’s Oncologic Drugs Advisory Committee on Thursday strongly supported changing clinical trials for non-small cell lung cancer drugs given in the perioperative setting, pointing out the need for a more nuanced approached to treatments before and after surgery.
The regulator on Wednesday provided recommendations to drugmakers for assessing the use of electronic health records and medical claims data to support their applications.
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
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