Brian Park, PharmD

AB-1005 is an investigational gene therapy based on AAV2 containing the human GDNF transgene.

The sNDA is supported by data from 3 clinical trials that evaluated brexpiprazole in combination with sertraline in adult patients with PTSD.

The CIFFREO study enrolled ambulatory male participants 4 to 7 years of age with a confirmed diagnosis of DMD.

Eladocagene exuparvovec is a one-time, recombinant adeno-associated virus serotype 2-based gene replacement therapy.

Consumers are being urged not to use the tests because of the increased risk of false results.

The phase 3 study evaluated the efficacy and safety of lumateperone as an adjunctive treatment to antidepressants in 485 patients with MDD.

The Repatha Pushtronix System will be discontinued as of June 30, 2024.

The approval was based on data from the pivotal phase 3 PRISMA-3 study that included adults with acute exacerbation of schizophrenia.

The prescribing information for Vigpoder carries a Boxed Warning associated with a risk for permanent vision loss.

The clearance was based on real-world data from the TrakStar platform, which included 1169 adolescents.

SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier, stabilizes proteins, and activates autophagy.

Results also showed significant reductions in brain amyloid plaque levels among patients in the donanemab arm as early as 6 months after initiating treatment.

The new injector device is intended to allow patients to self-administer Acthar Gel with fewer steps and designed to help with dexterity issues.

The sBLA is supported by data from the ADHERE study which evaluated the efficacy and safety of the SC formulation in 322 adults with CIDP.

PGN-EDODM1 is designed to restore cellular function by delivering a peptide-conjugated antisense oligonucleotide that blocks the toxic DMPK transcript CUG repeats.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for valbenazine oral granules.

Crinecerfort is an investigational, oral, selective corticotropin-releasing factor type 1 receptor (CRF1) antagonist.

The FDA has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia.

The ADA guideline aligns with FDA recommendations advising against codeine and tramadol use in pediatric patients.

The phase 3 study evaluated pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy who are taking background corticosteroids.

The FDA has approved the first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets.

Ingrezza has demonstrated consistently greater improvements in adults with chorea associated with HD from week 2 to 12 vs placebo.

The FDA has granted Orphan Drug designation to AOC 1044 for the treatment of Duchenne muscular dystrophy with mutations amenable to exon 44 skipping.

The FDA has accepted for review the NDA for glatiramer acetate depot 40 mg for the treatment of relapsing forms of multiple sclerosis.

The recalled products were distributed nationwide to wholesalers, drug chains, mail order pharmacies and supermarkets between June 2022 to May 2023.

GC5107B is a liquid solution containing 10% immunoglobulin G for IV infusion, manufactured from pooled human plasma from US donors.

Beyfortus is approved for the prevention of RSV lower respiratory tract disease in infants and children up to 24 months of age.

Treatment with the SC formulation of efgartigimod alfa plus hyaluronidase-qvfc led to a lower risk of relapse in adults with CIDP.

Positive data were announced from a phase 3 trial evaluating an investigational SC formulation of ocrelizumab in patients with MS.

The Food and Drug Administration (FDA) has approved Opill®, a progestin-only daily oral contraceptive, for over-the-counter (OTC) use.