Medicine

Can Consuming Micronutrients Affect Ulcerative Colitis Risk?

Researchers examined the association between micronutrient intake and the risk for ulcerative colitis.

Delta vs Omicron: Which Variant Has a Higher Risk for Long COVID?

Using a symptom tracker app, researchers assessed the risk for long COVID among patients infected with the Delta or the Omicron variant between 2 time periods.

Patisiran Promising for Transthyretin-Mediated Amyloidosis With Cardiomyopathy

The APOLLO-B study included patients 18 years of age and older with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy.

FDA to Review Resubmitted Application for Severe Burn Therapy NexoBrid

NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes.

Rebinyn Approval for Hemophilia B Expanded to Include Routine Prophylaxis

Rebinyn is a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life.

FDA Approves Oral Testosterone Replacement Therapy Kyzatrex

The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.

Guideline for Preventing Weight Gain in Women at Midlife

Panel recommends counseling all women aged 40 to 60 years on healthy eating and physical activity to maintain weight or prevent weight gain.

Identifying Risk Factors for Alzheimer Disease: Are They Modifiable?

Ines Moreno-Gonzalez, PhD, an adjunct associate professor of neurology, explains healthy aging can help reduce lifestyle risk factors for Alzheimer disease.

Bifunctional Biologic Gets Orphan Drug Status for Paroxysmal Nocturnal Hemoglobinuria

KP104 is a bifunctional, first-in-class biologic that works by selectively inhibiting the alternative and terminal pathways in the complement system.

AbbVie Seeks Crohn Disease Indication for Upadacitinib

The application is supported by data from the two phase 3 induction studies, U-EXCEED and U-EXCEL, and one phase 3 maintenance study, U-ENDURE.

Iomeron Allowed for Temporary Importation to Address Contrast Media Shortage

To address the ongoing COVID-19 related iodinated contrast media product shortage, Iomeron will be temporarily available in the US starting at the end of August 2022.

OTC Laxative Recall Expanded; Vi-Jon Investigating 3 Reports of Adverse Events

Immunocompromised individuals may be at an increased risk for invasive infections if a contaminated product is consumed.

Vaccines for Monkeypox Prevention: Jynneos and ACAM2000

An individual is considered fully vaccinated about 2 weeks after the second dose of Jynneos and 4 weeks after receiving ACAM2000.

Glycopyrrolate Injection 0.6 mg/3 mL Now Available in Ready-to-Administer, Prefilled Syringe

The Simplist ready-to-administer prefilled syringes minimize preparation steps for clinicians.

Oral NaV1.8 Inhibitor VX-548 Designated Breakthrough Therapy for Severe Acute Pain

The designation was based on data from two phase 2 proof-of-concept studies that evaluated VX-548 for acute pain following abdominoplasty or bunionectomy surgery.

Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications

The application is under review for relapsing forms of multiple sclerosis and Crohn disease.

QazCovid-in Vaccine Shows High Efficacy Against COVID-19 in Phase 3 Trial

Researchers assessed the safety and efficacy of the QazCovid-in COVID-19 vaccine.

Intranasal Therapy Misses Endpoint in Social Anxiety Disorder Trial

Patients received PH94B or placebo intranasally 20 minutes before an induced public speaking challenge to relieve symptoms of anxiety.

Hypertension Affects Efficacy of COVID-19 Vaccine With Inactivated Virus

What factors influence the effectiveness of COVID-19 vaccination with inactivated virus? Two studies of Indonesian health care workers explored this question.

FDA to Review Biosimilar Hyrimoz High Concentration Formulation

The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.