The FDA has signed off on Tonix's Tonmya as the first new treatment for fibromyalgia in more than 16 years.

Pfizer's Phase 3 trial of inclacumab in sickle cell disease misses its main goal but shows safety, with further updates on other drugs planned.

In 2022, Pfizer struck a $5.4 billion deal to acquire Global Blood. The centerpiece of the deal was a different sickle cell disease drug, Oxbryta, which won its FDA approval in 2019.

For Precigen’s full release here: Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent ...

Omeros’ efforts to get its transplant drug to market have already suffered one FDA rejection. Now, the biotech’s second shot at approval has been pushed back by three months.

The FDA approved Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, for the treatment of fibromyalgia in adult patients, according to a press release from Tonix Pharmaceuticals.

The FDA approved the adenoviral vector-based immunotherapy, zopapogene imadenovec-drba, for treatment of certain patients with recurrent respiratory papillomatosis. The indication applies to adult ...

FDA Approves Vizz, First Daily Eye Drop For Age-Related Blurry Vision Presbyopia is defined as age-related loss of near vision that affects nearly everyone over age 45.

The Food and Drug Administration is considering pulling its authorization of Pfizer’s COVID-19 vaccine for healthy children under five, and it could leave many kids unprotected from the virus.

Despite the FDA’s requests to remove the blood pressure tracking tool in Whoop’s new fitness tracker, the company has stated ...

FDA Approves Brain Tumor Drug Targeting New Mutation — First systemic therapy approved for H3 K27M-mutant diffuse midline glioma ...

The Trump administration’s policy goal of bringing of bringing drug manufacturing back to the U.S. is now expanding to APIs under a new executive order signed Wednesday.