Clinical Trials

Decibel Therapeutics Announces Results of DB-020 Clinical Trial

by Veronica Salib

At the end of June, Decibel Therapeutics announced success in the phase 1b clinical trials on DB-020 for cancer patients receiving cisplatin chemotherapy. DB-020 is a sodium thiosulfate (STS) drug...

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 Approves New Treatment for Large B-Cell Lymphoma

by Veronica Salib

Recently, the FDA approved a new second-line treatment for large B-cell lymphoma (LBCL). Lisocabtagene maraleucel is the generic name for Breyanzi, developed and marketed by Juno Therapeutics. As a...

Women Are Underrepresented in Clinical Trials, Leading to Health Inequity

by Veronica Salib

Contemporary Clinical Trials published a study by researchers at the Brigham and Women’s Hospital that shows women were underrepresented in clinical trials. This conclusion may be contributing to...

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...

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...

Researchers Discover Promising Compound That Kills Hard-to-Treat Cancer Cells

by Alivia Kaylor

Scientists from the University of Texas Health Science Center at San Antonio have found a new target for eradicating various hard-to-treat cancer cells in culture and animal models, which could...

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...

Novartis Gains FDA Approval for Follicular Lymphoma Cell Therapy

by Hayden Schmidt

Novartis’s Kymriah was granted accelerated FDA approval last week after the drug’s clinical trial results demonstrated an 86% overall response rate and a high level of safety. Patients with...

Coronavirus Rebound After Pfizer’s Paxlovid Oral Antiviral Drug

by Hayden Schmidt

On Tuesday, the CDC warned Americans about the potential for coronavirus recurrence after using Pfizer’s antiviral drug Paxlovid. CDC officials are not recommending any changes to the ordinary...

FDA Approves First Drug for Chronic Disease Eosinophilic Esophagitis

by Hayden Schmidt

Sanofi’s Dupixent received FDA approval for use in people suffering from eosinophilic esophagitis (EoE) after a double-blind, placebo-controlled trial proved the drug effectively reduces...

FDA Amends EUA For Pfizer-BioNTech’s COVID-19 Vaccine Booster

by Samantha McGrail

FDA recently amended the emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine booster to include individuals 5– 11 years of age at least five months after completing the...

FDA Lifts Clinical Hold on Gilead’s HIV Treatment, Lenacapavir

by Samantha McGrail

FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis...