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Pfizer says FDA approves Padcev-Keytruda combo for certain patients
Pfizer (PFE) and Astellas Pharma (ALPMY) (ALPMY announced that the U.S. Food and Drug Administration has approved PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 ...
Nature
FDA approves 100th small-molecule kinase inhibitor
“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 ...
Reuters
US FDA approves Bayer drug for specific type of lung cancer
Nov 19 (Reuters) - The U.S. Food and Drug Administration said on Wednesday that it has approved Bayer's (BAYGn.DE), opens new tab drug for patients with a form of lung cancer that has advanced or ...
Reuters
US FDA approves Arrowhead's genetic disorder drug
Nov 18 (Reuters) - The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals' (ARWR.O), opens new tab drug for a type of genetic disorder that causes extremely high levels of fat in the ...
Seeking Alpha
Arrowhead rises as FDA approves lead drug for rare disorder
Shares of Arrowhead Pharmaceuticals (ARWR) gained on Tuesday after the U.S. FDA approved its lead asset Redemplo (plozasiran) for adults with a rare genetic disorder called familial chylomicronemia ...
Medical Xpress
FDA approves Caplyta for major depressive disorder in adults
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 ...
MedCity News
FDA Approves Kura Oncology Leukemia Drug, Teeing Up Competition With Syndax Pharma
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 ...
FierceBiotech
Nuvalent shares lung cancer data, sparking race to FDA for would-be Pfizer rival
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 ...
The American Journal of Managed Care
FDA Approves Sibeprenlimab for Immunoglobulin A Nephropathy
Sibeprenlimab is approved for IgAN treatment, showing a 51.2% reduction in proteinuria in the VISIONARY trial. Administered subcutaneously every four weeks, it inhibits APRIL to reduce IgA levels.
Cure Today
FDA Approves First Interchangeable Biosimilar to Perjeta in HER2+ Breast Cancer
Poherdy is the first interchangeable biosimilar to Perjeta, approved for HER2-positive breast cancer, expanding access to targeted therapies. Biosimilars like Poherdy meet rigorous FDA standards, ...
The American Journal of Managed Care
FDA Approves Plozasiran to Reduce Triglycerides in Familial Chylomicronemia Syndrome
Plozasiran is the first FDA-approved drug for familial chylomicronemia syndrome, reducing triglycerides as an adjunct to diet. The phase 3 PALISADE trial showed significant triglyceride reduction with ...