April 30, 2025

FDA Approves FcRn Blocker for Broad gMG Use

The first FcRn blocker for both adult and pediatric generalized myasthenia gravis has been approved by the FDA, based on data showing sustained symptom improvement and IgG reduction in clinical trials.

Conexiant

April 30, 2025

New Phase III Data on Brensocatib Therapy

Phase III trial results show that once-daily brensocatib reduces pulmonary exacerbations and slows lung function decline in patients with bronchiectasis.

Conexiant

April 25, 2025

FDA Approves Penpulimab-kcqx for NPC

The FDA approved penpulimab-kcqx for first line and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Conexiant

April 24, 2025

FDA Warns of Topical Finasteride Risks

The FDA has issued a safety alert on compounded topical finasteride products, citing adverse events and emphasizing the lack of regulatory approval or safety evaluation.

Conexiant

April 24, 2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer

The FDA approved the combination of a PD-1 inhibitor and a CTLA-4 inhibitor for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer ...

The ASCO Post

April 23, 2025

FDA Targets Petroleum-Based Dyes in Food Supply

The FDA and HHS announced plans to eliminate petroleum-based synthetic food dyes, citing potential health risks and aligning with global safety standards.

Conexiant

April 18, 2025

Intranasal Diazepam Gains Expanded Approval for Pediatric Patients

“Approval of an immediate-use intranasal diazepam treatment that can be given at any time—even while a child is actively seizing—in this young age group is an important advance for the epilepsy community.”

Conexiant

April 18, 2025

FDA Approves New Spontaneous Urticaria Therapy

The FDA approved dupilumab as the first targeted therapy for chronic spontaneous urticaria in patients aged 12 years and older uncontrolled on antihistamines.

Conexiant

April 17, 2025

Phase 3 Trial Supports New Gonorrhea Drug

Trial shows oral gepotidacin is non-inferior to ceftriaxone plus azithromycin for treating uncomplicated urogenital gonorrhea.

Conexiant