FDA OKs Tdap Vaccine for Whooping Cough Protection Before Birth
The FDA announced approval of the first vaccine to be delivered through a pregnant mother to unborn babies for protection in the first 2 months of life. The tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine Boostrix is to be given during the third trimester of pregnancy to deliver antibodies to the developing […]
Gene Therapy for Degenerative Brain Disorder Wins FDA Nod
The FDA granted accelerated approval to elivaldogene autotemcel (eli-cel; Skysona), a gene therapy to treat early, active cerebral adrenoleukodystrophy (CALD) in boys ages 4 to 17 years, drugmaker bluebird bio announced Friday. Childhood CALD is a rare, neurologically debilitating form of adrenoleukodystrophy that generally occurs in young boys. It is caused by a mutation in […]
Beta-Thalassemia Gene Tx Gets Ringing Endorsement From FDA Advisers
An FDA advisory committee on Friday unanimously recommended betibeglogene autotemcel (beti-cel) for approval in patients with transfusion-dependent beta-thalassemia, a chronic inherited blood disorder. With a 13-0 vote, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said the benefits of the one-time, first-in-class lentiviral vector (LVV) gene therapy outweigh any of the risks associated with the […]
Prior Authorization Back in the Spotlight on Capitol Hill
WASHINGTON — Prior authorization, that oft-maligned process of getting insurer approval prior to performing a procedure or prescribing a drug, is in the spotlight once again, on several fronts. On Capitol Hill, the issue began to bubble up in late April, when the Department of Health and Human Services (HHS) Office of Inspector General (OIG) […]
Rare Seizure Disorder Gets Its First Drug Approval
Ganaxolone (Ztalmy) won approval to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD), a rare genetic epilepsy, in patients ages 2 and older, the FDA announced. Ganaxolone is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor. The oral therapy is the first drug approved specifically for […]
Why You Want Your Therapist To Like You So Badly
Whenever Emma Flint meets a new therapist, she craves their approval — even when she doesn’t like them. While she wants everyone to like her, the need is different with therapists. “With a therapist, it feels more intense; it almost becomes all-consuming,” said Flint, a writer and freelance journalist. “I want them to like me […]
Year in Review: Lung Cancer
Lung cancer developments in 2021 were highlighted by the approval of an agent for a target once considered “undruggable,” the first approval of an adjuvant immunotherapy, broader screening recommendations from the U.S. Preventive Services Task Force (USPSTF), and more. First Approvals Targeting KRAS and a Rare EGFR Mutation In May, the FDA granted accelerated approval […]
Shingrix OK’d For Immunocompromised Adults
FDA expanded the approval of Shingrix, an adjuvanted recombinant zoster vaccine, for adults at increased risk of shingles due to immunosuppression, manufacturer GlaxoSmithKline (GSK) announced on Monday. The expanded indication is for adults ages 18 and older at a greater risk of shingles due to “immunodeficiency or immunosuppression caused by known disease or therapy.” The […]