The European Commission has the final word on drug approvals but it generally follows EMA’s recommendation within a couple of months.
AbbVie Inc said on Tuesday the U.S. Food and Drug Administration placed a partial clinical hold on all trials of its cancer drug Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the Venclexta arm of the late-stage study.
MADRID: Two AstraZeneca drugs tackling lung cancer in different ways delivered impressive clinical results on Saturday, helping the British group offset July’s big clinical trial setback in the disease. Particularly notable was the success of the infused immunotherapy medicine Imfinzi in helping non-small cell lung cancer patients with inoperable mid-stage disease that has not spread widely around the body. Chief Executive Pascal Soriot said it gave AstraZeneca a chance to intervene earlier in lung cancer,…
WASHINGTON: A new type of cancer drug that takes the brakes off the body's immune system has given drugmakers some remarkable wins against the deadly disease, but a top U.S. regulator says too many companies are focused on the same approach.
LONDON: Efforts by Novartis to defend its blockbuster cancer drug Afinitor against competitors got a boost on Thursday from European regulators, who approved it for use on certain types of advanced gastrointestinal and lung neuroendocrine tumors.