Latest News

Can Consuming Micronutrients Affect Ulcerative Colitis Risk?

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

Pfizer Ends Development of Drug for LMNA-Related Dilated Cardiomyopathy

PF-07265803 is an investigational selective, oral, small-molecule inhibitor of the p38a mitogen activated protein kinase pathway.

Many Sponsors Don’t Share Data From Trials Supporting Cancer Drug Approvals

Many clinical trials supporting cancer drug approvals are ineligible for individual participant data sharing, a new study suggests.

Diet-Induced Remission in Pediatric Crohn Disease Linked to Metabolome Changes

Researchers examined changes in fecal metabolites resulting from either the Crohn disease exclusion diet plus enteral nutrition or the exclusive enteral nutrition diet and the association with remission.

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.

Cimerli Approved as Interchangeable Biosimilar to Lucentis

The approval of Cimerli was based on a comprehensive analytical, preclinical and clinical program including the phase 3 COLUMBUS-AMD study.

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.

Ibrexafungerp Under Review for Prevention of Recurrent Vulvovaginal Candidiasis

The sNDA is supported by data from the phase 3 CANDLE study.

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.

Stelara Approved for Pediatric Psoriatic Arthritis

The approval is supported by evidence from adequate and well-controlled studies of Stelara.

Study Investigating Oral JAK Inhibitor for Alopecia Areata Meets Endpoint

CTP-543 is an investigational oral selective inhibitor of JAK1 and JAK2.

Zoryve Cream Approved for Plaque Psoriasis

The approval was based on data from the two phase 3 trials that included patients aged 12 years and older with mild to severe plaque psoriasis.

Trial Evaluating Nivolumab Plus Ipilimumab for Localized RCC Misses Endpoint

The CheckMate -914 trial included patients with localized RCC who underwent radical or partial nephrectomy and who were at high risk of relapse.

Noninferiority of Once-Weekly Insulin Icodec Demonstrated in Two T2D Trials

The 26-week ONWARDS 3 and 4 clinical trials evaluated the efficacy and safety of insulin icodec in adults with type 2 diabetes.

Glaucoma Progression May Result From Frequent Cigarette Use

Modifying smoking behavior may lower the risk of developing severe glaucoma or losing vision.

“Substantial” Prevalence of Advanced Colorectal Neoplasia Found in Adults Aged 45 to 49 Years

Researchers sought to determine the prevalence and risk factors for colorectal neoplasia in adults younger than 50 years.

PENS Device Cleared To Treat Pain Following C-Section Delivery

Approval was based on a prospective study that included 44 participants who underwent C-section delivery.