Nuvalent has reported phase 1/2 lung cancer data, teeing the biotech up to talk to the FDA about an approval filing that could establish its neladalkib as a challenger to Pfizer’s Lorbrena. The ALKOVE ...

Nov 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved Kura Oncology (KURA.O), opens new tab and Japanese partner Kyowa Kirin's (4151.T), opens new tab once-daily pill, Komzifti ...

The FDA has approved a Kura Oncology drug developed for cases of acute myeloid leukemia (AML) carrying a certain genetic signature, giving the biotech its first commercial asset and the opportunity to ...

“It was a really hard sell,” recalls Druker, an oncologist and CEO of the Oregon Health & Science University Knight Cancer Institute, decades on. There were seemingly valid concerns at the time, he ...

The U.S. Food and Drug Administration has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults. This approval marks ...

Rybelsus is now also indicated for cardiovascular risk reduction in adults with Type 2 diabetes who are at high risk, including those who have not had a prior CV event. This new indication makes ...

U.S. drugmaker Pfizer has clinched a $10 billion deal for obesity drug developer Metsera, capping a fierce biotech bidding war between the New York-based pharma giant and Danish rival Novo Nordisk.

For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition develops into multiple myeloma. The FDA has approved Johnson & Johnson’s ...

Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events. Johnson & Johnson won U.S. approval to sell the ...

The updated indication allows the use of Rinvoq prior to the use of tumor necrosis factor blocking agents in certain patients. "At AbbVie, we are committed to addressing the ongoing needs of patients ...

The FDA approved linaclotide (Linzess) capsules to treat irritable bowel syndrome with constipation (IBS-C) in children age 7 years and older, the agency announced Wednesday. The decision makes the ...

Boehringer Ingelheim has secured FDA approval for its PDE4 inhibitor nerandomilast (Jascayd) for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and fatal lung disease. Nerandomilast ...