US FDA approves GSK's blood cancer treatment

The U.S. Food and Drug Administration has approved British drugmaker GSK's blood cancer drug, Blenrep, in one combination regimen, the company said on Thursday, clearing the way for its return to the ...
Healio

FDA approves Eydenzelt as biosimilar referencing Eylea

Please provide your email address to receive an email when new articles are posted on . Eydenzelt is approved for four retinal diseases, including wet age-related macular degeneration and diabetic ...

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
Cure Today

FDA Approves Libtayo for Cutaneous Squamous Cell Carcinoma Treatment

Libtayo is approved for adjuvant treatment in high-risk CSCC patients post-surgery and radiation, showing significant disease-free survival benefits in the C-POST trial. The C-POST trial excluded ...
Healio

FDA approves nerandomilast for idiopathic pulmonary fibrosis

Please provide your email address to receive an email when new articles are posted on . The FDA based nerandomilast’s approval on results from two trials, one of which was the FIBRONEER-IPF trial.
Becker's Hospital Review

FDA approves first new treatment for rare disease in 10 years

The FDA has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis, a rare, progressive lung disease that can cause scarring and breathing difficulties. The approval marks the ...
Medscape

FDA Gives Nod to Nerandomilast for Severe Lung Disease

The FDA has approved nerandomilast tablets for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, according to an FDA press release. Nerandomilast, marketed as Jascayd by its manufacturer ...
Catholic News Agency

U.S. bishops: FDA approval of generic abortion drug is a ‘shocking inconsistency’

The U.S. Catholic bishops sharply criticized the Trump administration’s recent approval of the generic abortion drug mifepristone, saying that women and children deserve better care. The Food and Drug ...
Monthly Prescribing Reference

Aflibercept Biosimilar Eydenzelt Gets FDA Approval

Credit: Celltrion Edenzelt is a vascular endothelial growth factor inhibitor. Findings from the phase 3 study showed therapeutic equivalence between the biosimilar and reference product. The Food and ...

FDA issues safety alert for radiofrequency microneedling

The U.S. Food and Drug Administration (FDA) is warning consumers, patients and health care providers about the potential risk ...
Benzinga.com

Regeneron's Libtayo Gains FDA Approval To Reduce Recurrence Risk In Skin Cancer Patients

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients ...
Nature

FDA approves BTK inhibitor for chronic hives

Novartis has secured FDA approval for its BTK inhibitor remibrutinib (Rhapsido) for the treatment of chronic spontaneous urticaria. Remibrutinib is the sixth BTK inhibitor to market in the US, and the ...