FDA Archives

FDA Approval Of Kerendia To Help Slow Kidney Disease And Failure Associated With Type 2 Diabetes

July 16, 2021 Rod Washington

New Kidney Drug Therapy and the FDA The American Association of Kidney Patients, the largest kidney patient consumer and caregiver organization in the nation, today issued the following statement regarding the recent approval by the U.S. Food and Drug Administration of a new drug therapy, Kerendia by Bayer Pharmaceuticals, designed to slow chronic kidney disease progression and reduce the risk…

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

July 2, 2021 Rod Washington

Alternative Has Been in Global Shortage Since 2016 The U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for…

FDA Approves First Oral Blood Thinner for Children

June 22, 2021 Rod Washington

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral…

FDA Approves a Nasal Antihistamine for Nonprescription Use

June 17, 2021 Rod Washington

Approval is a First-in-class and was Enabled by the Prescription to Nonprescription Switch Process The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six…

FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety Efforts

June 2, 2021 Rod Washington

Affordable Traceability Tools The U.S. Food and Drug Administration launched a challenge to spur the development of affordable, tech-enabled traceability tools to help protect people and animals from contaminated foods by enabling the rapid identification of their sources and helping remove them from the marketplace as quickly as possible. The FDA New Era of Smarter Food Safety Low- or No-Cost…

FDA Seeks Further Investments in Critical Public Health Infrastructure and Medical Product Safety Programs

May 31, 2021 Rod Washington

Fiscal Year 2022 Budget Request Reflects Nearly 8% Increase from Previous Year and Focuses on Agency’s Immediate Priorities The U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget – a nearly 8% ($477 million) increase over the agency’s FY 2021 funding level for investments in…

FDA Approves First Targeted Therapy for Previously Resistant Lung Cancer Mutation

May 28, 2021 Rod Washington

Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for…

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

May 22, 2021 Rod Washington

The U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today. “Advances in precision oncology continue…

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

March 27, 2021 Rod Washington

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. “Today’s action is a positive step…

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

January 5, 2021 Rod Washington

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive…