A dried fish product sold in New York and New Jersey has been given the highest level of food safety alert by the FDA.

The accelerated FDA approval of Bayer's Hyrnuo covers treatment of advanced cases of non-small cell lung cancer with HER2 mutations. It will compete against an HER2-targeting Boehringer Ingelheim pill approved in August.

For decades, hormone replacement therapies carried warnings that they increased the risk of cancer and dementia. Now, that study is being dismissed, and the warning is being removed.

The FDA has granted an accelerated approval for the use of sevabertinib in patients with nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2) tyrosine kinase domain (TKD) activating mutations. 1 The approval allows for patients to take sevabertinib in a 20-mg oral dose twice per day.

The FDA approved epcoritamab-bysp in combination with lenalidomide and rituximab for patients with relapsed or refractory follicular lymphoma and as monotherapy for these patients after two or more lines of systemic therapy.

The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the opposite direction.

Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD),

The FDA has granted 510(k) clearance and a label expansion for a transcranial magnetic stimulation device to treat patients aged 15 to 21 years with major depressive disorder, according to a press release from the manufacturer.

The FDA accepted a new drug application for zidesamtinib for previously treated locally advanced or metastatic ROS1-positive non-small cell lung cancer.