Brian Park, PharmD

The FDA has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active Crohn disease.

Consumers are being warned not to purchase or use Nose Slap or Soul Slap as these products primarily contain ammonia.

Tirzepatide is a once-weekly, dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

The FDA will review the BLA for the SC administration of vedolizumab (Entyvio) as maintenance therapy for adults with ulcerative colitis.

The FDA has expanded the approval of Trikafta to include children with cystic fibrosis ages 2 through 5 years.

The FDA has approved Vowst (fecal microbiota spores, live-brpk) to prevent the recurrence of Clostridioides difficile infection in adults.

Akorn has initiated a voluntary recall of various within-expiry drug products due to a company operations shutdown.

A PDUFA target date of December 16, 2023 has been set for the application.

The FDA has granted full approval to Keytruda (pembrolizumab) for patients with unresectable or metastatic MSI-H/dMMR solid tumors.

Osemitamab is a high affinity, humanized antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-Claudin18.2 monoclonal antibody.

Results showed that 20.3% of patients treated with risankizumab achieved clinical remission at week 12 compared with 6.2% of patients who received placebo.

The sNDA is supported by data from the phase 3 DINAMO trial, which include patients 10 to less than 18 years of age with type 2 diabetes who are currently receiving metformin, insulin, or both.

The FDA has approved a citrate-free, high-concentration formulation of Hyrimoz injection, a biosimilar to Humira.

Positive results were announced from a phase 3 study evaluating atezolizumab and bevacizumab in adults with early-stage liver cancer.

The FDA has accepted the resubmitted NDA for obeticholic acid for the treatment of patients with precirrhotic liver fibrosis due to NASH.

Rebyota is a fecal microbiota suspension for rectal administration.

TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, and eliminate metastasis.

Austedo XR is a vesicular monoamine transporter 2 inhibitor.

CHAPLE disease is a rare genetic disorder caused by mutations in the CD55 gene.

The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection.

The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.

The approval was based on data from the phase 2 MOUNTAINEER trial, which included patients with HER2-positive unresectable or metastatic colorectal cancer.

Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.

OPNT003 is an intranasal formulation containing the high affinity opioid antagonist, nalmefene.

Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs.

Kineret is an interleukin-1 receptor antagonist.

The designation is supported by data from the 12-week, randomized, double-blind phase 2 FILLMORE trial.

The 2022 CDC Clinical Practice Guideline is intended to help clinicians weigh the benefits and risks of opioids and alternative pain treatments for outpatients.

Findings showed that the booster dose elicited robust antibody responses comparable to, or exceeding levels associated with the efficacy data in the primary series of the vaccine.

SKOUT is designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists.