A breakthrough FDA-approved treatment is changing how genetic deafness is treated.

AbbVie Inc. ABBV announced that the FDA has granted a Breakthrough Therapy designation to Venclexta (venetoclax) in combination with azacitidine for the potential treatment of adult patients with ...

Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, tolebrutinib, for treating adults with non-relapsing secondary progressive ...

uniQure (NASDAQ:QURE) shares added ~39% in the premarket on Thursday after the Dutch biotech announced that the FDA granted Breakthrough Therapy designation for its gene therapy candidate AMT-130. The ...

Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. On November 22 nd, the Food and Drug Administration (FDA) approved ...

The nation's first sanctioned gene therapy — approved Wednesday to fight leukemia that resists standard therapies — will cost $475,000 for a one-time treatment, its manufacturer announced. The Food ...

What is the price of saving a life? How much is it worth to a person to avoid monthly blood transfusions for decades? How much is it worth to partially restore someone’s eyesight? When it comes to ...

The FDA has granted Breakthrough Therapy Designation (BTD) to SAB Biotherapeutics Inc's (NASDAQ:SABS) SAB-176, an investigational therapy for post-exposure prophylaxis for Type A and Type B influenza ...

The newest of the new in gene therapy: 'Tag and target and exchange' New research in the FASEB Journal suggests that site-specific recombinases from either yeast or phages act not only to tag and ...