Cecilia Pessoa Gingerich
MD Magazine
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Past articles by Cecilia:
FDA Approves Oral Contraceptive Slynd
The estrogen-free pill allows for a 24-hour missed pill window while maintaining efficacy in preventing pregnancy. → Read More
FDA Approves Teduglutide for Pediatric Use
Teduglutide (Gattex) has been approved as an injection for pediatric patients 1 year of age and older with Short Bowel Syndrome. → Read More
FDA Approves Aflibercept for Diabetic Retinopathy
Aflibercept (Eylea) is an anti-VEGF treatment administered as an intravitreal injection. → Read More
FDA Approves sBLA of incobotulinumtoxinA for Blepharospasm
The FDA has expanded the indication for incobotulinumtoxinA (Xeomin) to include treating blepharospasm (involuntary blinking) in adults. → Read More
FDA Clears 6-Lead KardiaMobile ECG Device
The KardiaMobile 6L device is the first FDA-cleared 6-lead electrocardiogram (ECG) device for personal use. → Read More
Brian Toy, MD: Incidence of Uveitis in the US
Using a national medical claims database, investigators found the incidence and prevalence of uveitis in the US. → Read More
FDA Approves Combination Lotion for Plaque Psoriasis
The lotion, Duobrii, combines halobetasol propionate, a topical steroid, with tazarotene, a retinoid, to provide 2 mechanisms of action for treating plaque psoriasis. → Read More
FDA Approves Risankizumab for Plaque Psoriasis
Risankizumab (Skyrizi) is now approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. → Read More
STR1VE Trial in SMA1 Demonstrates Positive Interim Results
As of September 2018, 95% of children treated with Zolgensma were alive and did not require permanent ventilation. → Read More
FDA Accepts NDA for Riluzole Oral Film for ALS Treatment
Riluzole oral film (Exservan) was developed as an option for patients with ALS who have difficulty swallowing medication. → Read More
Robert Bober, MD: Designing a Better Hospital Room
New features include wireless vital monitors, red lighting for nighttime, and surfaces and linens infused with antimicrobial copper. → Read More
FDA Issues CRL for Rizaport Acute Migraine Treatment
The Complete Response Letter highlights issues in the Chemistry, Manufacturing, and Controls section of the application. → Read More
sNDA Submitted for Icosapent Ethyl for MACE Reduction Indication
The application to the FDA for icosapent ethyl seeks a new indication to reduce the risk of major adverse cardiovascular events. → Read More
FDA Approves Certolizumab for Non-radiographic Axial Spondyloarthritis
Certolizumab pegol (Cimzia) is the first FDA-approved treatment for the condition. → Read More
FDA Designates PRM-151 Breakthrough Therapy for Idiopathic Pulmonary Fibrosis
The investigational anti-fibrotic immunomodulator is being investigated for respiratory, oncology, hepatology, and nephrology indications. → Read More
IV Meloxicam Receives Second CRL from FDA
The FDA’s response noted that the onset and duration of intravenous meloxicam would not meet prescriber expectations for an IV drug. → Read More
FDA Issues CRL for Sotagliflozin
The FDA’s decision regarding sotagliflozin (Zynquista), an investigational treatment for type 1 diabetes, followed a split Advisory Committee vote in January. → Read More
Empagliflozin Reduces Heart Failure Re-Hospitalization, Mortality
Among participants of the EMPA-REG OUTCOME trial who experienced heart failure, empagliflozin was associated with lower rates of short-term re-hospitalization and death. → Read More
Midwest Hospital Infective Endocarditis Rates Spiked During Opioid Crisis
Admissions for infective endocarditis related to intravenous drug use increased 436% from 2012-2017 at an Ohio medical center. → Read More
FDA Accepts NDA for Investigational Insomnia Drug Lemborexant
An FDA decision on the application is expected by December 27, 2019. → Read More