FDA

Paxlovid Reduces Patient Hospitalization Risk by 5 Times

by Veronica Salib

A study published in Epic Research found that, after taking Paxlovid, COVID-19 patients were five times less likely to be hospitalized and ten times less likely to die. Paxlovid is “an oral...

Decreased COVID-19 Vaccination Rates: A Pediatric Health Risk

by Veronica Salib

The Kaiser Family Foundation (KFF) recently found that pediatric COVID-19 vaccination rates in children under 5 years old have decreased despite the age bracket’s very recent eligibility....

Decentralization Tools May Improve Cancer Clinical Trial Enrollment

by Veronica Salib

According to a cross-sectional survey study published in JAMA, remote and decentralization tools can improve clinical trial enrollment and participation in cancer studies.  Recently, many...

HRA Pharma Submits FDA Application for First OTC Birth Control Pill

by Veronica Salib

HRA Pharma has submitted an FDA application to allow the OTC sale of their progestin-only daily birth control pill, Opill. If this application is approved, this will be the first birth control pill...

FDA Expands EUA to Allow Pharmacists to Prescribe Paxlovid

by Veronica Salib

Recently, the FDA expanded its emergency use authorization (EUA) for Paxlovid, an oral antiviral medication. This expansion permits pharmacists to prescribe this antiviral medication to patients...

FDA Releases Drug Safety Communication regarding Cancer Drug, Copiktra

by Veronica Salib

On June 30, the FDA released a drug safety communication that warned against the risks associated with Copiktra. Copiktra, also called duvelisib, is a cancer drug used to treat relapsed or...

FDA Expanded Approval of Skyrizi for Treatment of Crohn’s Disease

by Veronica Salib

The FDA recently approved Skyrizi as a treatment for moderate to severely active Crohn’s disease. Crohn’s disease is an inflammatory bowel disease (IBD) with many painful symptoms that can...

Pfizer Acquires ReViral for $525M, Renews Pharma Acquisition Spree

by Hayden Schmidt

Pfizer has announced or completed the acquisition of four pharmaceutical companies in the past year. The most recent of which incorporated ReViral Ltd, adding another antiviral drugmaker to...

FDA Approved Weight-Management Treatment for Bardet–Biedl Syndrome

by Veronica Salib

The FDA recently approved the Imcivree (setmelanotide) injection as a weight-management treatment for adults and children over 6 with Bardet–Biedl Syndrome (BBS). BBS is a relatively...

Beta Bionics Shares Clinical Trial Data on Bionic Pancreas for Type 1 Diabetes

by Veronica Salib

Earlier this month, Beta Bionics presented clinical trial data to the American Diabetes Association (ADA) on its insulin-only bionic pancreas — called the iLet Bionic Pancreas — for use in...

Could the Approval of Albrioza by Health Canada for ALS Impact the FDA Ruling?

by Veronica Salib

This week, Health Canada announced its approval of Albrioza (created by Amylyx Pharmaceuticals) for the treatment of ALS. It has been the only newly approved treatment for ALS since 2018. The drug is...

FDA Accepts Biologic Application for Keytruda Treatment of Lung Cancer

by Hayden Schmidt

The FDA recently accepted Merck’s Biologics License Application (BLA) for its cancer medication Keytruda. Promising results from interim clinical trial data indicated that Keytruda improved...

Olumiant Becomes the First FDA-Approved Systemic Treatment for Alopecia Areata

by Veronica Salib

Monday’s FDA approval of Olumiant for the treatment of Alopecia Areata (AA) marks a historical change in the procedures used to address Alopecia Areata as it is the first systemic therapy for the...

Eli Lilly Sued by Whistleblower for Pharmaceutical Manufacturing Issue

by Hayden Schmidt

A former employee of Eli Lilly is suing the company, claiming she was terminated after exposing issues with pharmaceutical manufacturing practices at one United States operation. Amrit Mula said that...

Bluebird Bio’s Rare Disease Gene Therapies Recommended for FDA Approval

by Hayden Schmidt

Last week, the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 15 – 0, concluding that the benefits of bluebird bio’s gene therapy to treat cerebral...

FDA Recommends Emergency Use for Novavax Coronavirus Vaccine

by Hayden Schmidt

The FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted 21­­­­­ to 0 in favor of recommending the Novavax coronavirus vaccine for emergency...

FDA Refuses to File Aeglea Biologics License Application

by Hayden Schmidt

Aeglea BioTherapuetics announced that it had failed to secure a biologics license application (BLA) from the FDA after administrators issued a refusal to file for the company’s biologic...

Pfizer-BioNTech’s Expanding Coronavirus Vaccine FDA Approval

by Hayden Schmidt

Late last month, Pfizer announced its coronavirus vaccine clinical trial results, indicating that a three-dose regimen of the Pfizer-BioNTech vaccine was safe and effective for children older than 6...

Nephron Pharmaceuticals Recalls 2.1 Million Doses of Medicine, Medical Equipment

by Alivia Kaylor

According to the FDA’s enforcement report, Nephron Sterile Compounding Center, in Columbia, South Carolina, is recalling 2,158,351 medical products including syringes and bags because of a lack...

Study Finds Vaccination During Pregnancy Decreases Baby’s COVID-19 Risk

by Alivia Kaylor

Data from a study published in February's CDC Morbidity and Mortality Weekly Report suggest that COVID-19 vaccination during pregnancy provides substantial protection for mother and baby. This...