US FDA approves Celcuity's breast cancer drug
July 14 (Reuters) - The U.S. FDA has approved Celcuity's drug for an advanced form of breast cancer, the regulator said on Tuesday, making it the company's first product to gain market entry and ...
The Cardiology Advisor
June 2026: Notable Drug Approvals
FDA Drug Approvals and Regulatory Updates Drug Pharmacologic class Indication More information Cardiovascular Disease Tryngolza (olezarsen) Apolipoprotein C-III-directed antisense oligonucleotide ...
AOL
FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance
Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved IBRANCE ® (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy ...
Merck, Pfizer, Astellas Bladder Cancer Treatment Approved by FDA
The Food and Drug Administration approved a combination treatment by Merck & Co., Pfizer, and Astellas Pharma for a hard-to-treat form of bladder cancer. The agency greenlit Merck's Keytruda and its ...
Seeking Alpha
Pfizer granted FDA label expansion for breast cancer drug, Ibrance
The U.S. Food and Drug Administration on Wednesday approved a label expansion for Pfizer’s (PFE) breast cancer therapy, palbociclib, marketed as Ibrance. Accordingly, the kinase inhibitor will be ...
FiercePharma
Pfizer scores 1st expansion in 7 years for breast cancer blockbuster Ibrance
It’s been seven years since Pfizer scored an expansion for its breast cancer blockbuster Ibrance, and during that time, the drug has started to lag sales of two others in its class—Eli Lilly’s ...
Morningstar
FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance
First and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status Approval based on data from the collaborative Phase 3 PATINA trial, which showed a 24% risk reduction in ...
The American Journal of Managed Care
FDA Approves Palbociclib for HR+, HER2+ Breast Cancer Maintenance
FDA clearance establishes the first CDK4/6 inhibitor indication spanning HR+ metastatic disease regardless of HER2 status, creating a new maintenance strategy for HR+/HER2+ tumors. PATINA randomized ...
STAT
Pharmalittle: We’re reading about FDA reforming clinical trials, a Pfizer setback, and much more news
Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter ...
The Denver Post
Colorado receives FDA permission to import cheaper drugs — including Ozempic — from Canada
Getting your Trinity Audio player ready... Colorado finally has federal permission to start importing cheaper prescription drugs from Canada, but the state may not have any sellers to work with.
Pfizer, Astellas expand PADCEV-Keytruda label with FDA nod in bladder cancer
On Friday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s PFE and Astellas Pharma Inc.’s ALPMF ALPMY ...
Hosted on MSN
FDA expands Pfizer's Ibrance label for frontline maintenance in advanced breast cancer
On Wednesday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s PFE Ibrance (palbociclib) regimen for frontline maintenance for metastatic breast cancer. The approval covers Ibrance ...