Tag Archive for: U.S. Food and Drug Administration (FDA)

The FDA on Tuesday rejected Orexo’s application for OX124, its high-dose naloxone nasal spray for the rescue treatment for opioid overdose.

Sarepta Therapeutics’ gene therapy Elevidys will be available to Duchenne muscular dystrophy (DMD) patients who are at least 4 years old, regardless of whether they can walk, the FDA said Thursday.

PTC Therapeutics announced Thursday that its Huntington’s disease candidate PTC518 is no longer subject to an FDA partial clinical hold after it showed positive interim results from a Phase II study.

The FDA placed a partial clinical hold on three of Zentalis Pharmaceuticals’ cancer treatment studies following two patient deaths.

The FDA on Monday greenlit Merck’s 21-valent pneumococcal conjugate vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.

The FDA has slapped a partial clinical hold on BioNTech and MediLink’s Phase I study of an antibody-drug conjugate candidate for types of non-small cell lung cancer or breast cancer, following multiple patient deaths.

The U.S. drug regulator has pushed back its decision on Moderna’s (MRNA.O) respiratory syncytial virus (RSV) vaccine due to “administrative constraints” and will complete the review by the end of this month, the company said on Friday.

The FDA on Thursday greenlit the label expansion of AstraZeneca’s subcutaneous IL-5 receptor blocker Fasenra (benralizumab), which can now be used as an add-on maintenance treatment for severe eosinophilic asthma in children six to 11 years of age.

Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson’s disease, sending its shares down 9% in early trade.

The FDA on Friday approved AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2-positive solid tumors in adults who have undergone prior systemic treatment and have no alternative treatment options.