FDA - Pharmacy Technician Pulse

FDA Approves Nitisinone for Treatment of Alkaptonuria

Drug Topics

JUNE 19, 2025

The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The medication is expected to launch in July 2025. REFERENCES 1.

FDA

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FDA Approves Widaplik for Treatment of Hypertension

Drug Topics

JUNE 9, 2025

The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. References 1.

FDA

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Experts Weigh In on What FDA's Removal of REMS for CAR T Means for Patients, Pharmacists

Pharmacy Times

JULY 14, 2025

Debra Patt, MD, PhD, MBA, and Houston Holmes, MD, discuss the ramifications of the FDA's removal of REMS requirements for approved chimeric antigen receptor (CAR) T-cell (CAR T) therapies.

FDA

FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira

Drug Topics

MAY 28, 2025

This designation follows Hadlimas low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.

FDA

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

FDA

FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency

Drug Topics

MAY 29, 2025

The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.

FDA

Eli Lilly Adds Highest Doses of Zepbound to Online Pharmacy Platform

Drug Topics

JUNE 16, 2025

1 "Lilly was the first company to offer a self-pay solution for an FDA-approved obesity medication, and we continue to work to expand coverage for Zepbound. mg and 15 mg vials of tirzepatide starting July 7, with shipments beginning in early August. .

Compounding

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FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted

The FDA Law Blog

JULY 8, 2025

Snow — Recently, FDA announced a deadline shift, although the Agency did so quietly. Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer. By Charles D. What does this mean?

FDA

FDA Documentation Communication

Key Differences Between FDA-Approved RSV Vaccines

Pharmacy Times

JULY 11, 2025

Panelists discuss the 3 FDA-approved RSV vaccines for high-risk adults—2 recombinant protein-based (1 adjuvanted, 1 bivalent) and one mRNA-based—highlighting differences in formulation, mechanism, and preparation, and emphasizing the importance of education to address misconceptions and guide appropriate vaccine selection.

Vaccines

Vaccines FDA

FDA loosens restrictions on first-gen CAR-T therapies

pharmaphorum

JUNE 30, 2025

There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

FDA

FDA grants orphan drug designation to antibody-mediated rejection treatment

Pharmafile

JUNE 26, 2025

Sanofi has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to riliprubart for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

FDA

FDA Immunization

FDA approves Widaplik for hypertension

The Checkup by Singlecare

JUNE 16, 2025

Food and Drug Administration (FDA) has approved Widaplik, a new triple combination medication designed to treat high blood pressure in adults. The post FDA approves Widaplik for hypertension appeared first on The Checkup. George Medicines has not yet announced pricing for Widaplik. When will Widaplik be available?

FDA

FDA Packaging Dosage

TikTok Videos on IBD Provide Low Quality Information

Drug Topics

JUNE 6, 2025

link] Recent Videos Related Content FDA Grants Expanded Interchangeability Designation to Yuflyma Ashley Gallagher May 23rd 2025 Article Adalimumab-aaty (Yuflyma) prefilled syringes and autoinjectors are now fully interchangeable with the reference product adalimumab (Humira) across marketed dosage forms and strengths.

FDA

FDA Mayo Clinic Immunization Specialty Pharmacies

FDA Approves Linvoseltamab-Gcpt for Treatment of Relapsed or Refractory Multiple Myeloma

Pharmacy Times

JULY 2, 2025

The treatment becomes the first approved BCMAxCD3 bispecific antibody with the potential to achieve biweekly or monthly dosing in patients with relapsed/refractory multiple myeloma.

FDA

Independent Pharmacists’ Unique Role During Disaster Management Efforts

Drug Topics

JUNE 11, 2025

Similar to Phillips’ idea of planning ahead, the FDA also has detailed provisions for patients to take during power outages, floods, or other events that compromise their ability to manage their medications. “An Taking precautions for storing medications and supplies is key to being prepared,” the FDA wrote. Innov Pharm. 2023;8(1):25.

Health and Personal Care Stores

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Guiding Patients Through Allergy Medication Safety: Pharmacists’ Role Following FDA Warning on Cetirizine and Levocetirizine

Pharmacy Times

JULY 8, 2025

The FDA is warning of rare severe itching after stopping long-term use of popular allergy medications cetirizine and levocetirizine, urging patient education.

FDA

Mark Cuban Cost Plus Drugs, 9amHealth Collaborate to Make Obesity Medications Affordable

Drug Topics

JUNE 18, 2025

Statins Have No Additional Antidepressive Effects as Add-On Treatment Ashley Gallagher June 5th 2025 Article Investigators found that simvastatin added to escitalopram for patients with obesity and major depressive disorder did not have increased antidepressive effects.

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Q&A: Expert Highlights Importance of Trusted Sources for Vaccine Information

Drug Topics

JULY 6, 2025

Knockel: I'm encouraging patients to talk to trusted health care professionals and to not get their advice from social media or the internet or other strangers, focusing on the fact that vaccines have been studied before, during, and after FDA approval.

Vaccines

Vaccines Immunization Insurance Communication

Pharmacist Involvement Helps Reduce Time to A1c Target

Drug Topics

JUNE 13, 2025

Low Sodium DASH Diet May Reduce Blood Pressure in Patients With T2D Killian Meara June 10th 2025 Article A modified DASH diet with lower sodium optimized for patients with type 2 diabetes reduced both systolic and diastolic blood pressure.

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GLP-1s Effective as Adjunctive Therapy in Patients with T1D, Obesity | ADA 2025

Drug Topics

JULY 2, 2025

3,4 Since then, several other formulations have received FDA approval, leading to research developments of multiple GLP-1s for treating people with overweight or obesity. image credit: photoopus / stock.adobe.com The first GLP-1RA approved for use in the US was exenatide (Byetta) in 2005 for patients with type 2 diabetes (T2D).

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Riliprubart Receives FDA Orphan Drug Designation for AMR in Solid Organ Transplantation

Pharmacy Times

JULY 14, 2025

This designation is significant because there are no FDA-approved treatments for transplant recipients with or preventing antibody-mediated rejection (AMR).

FDA

Patients with ultra-rare diseases worry new FDA rules will leave them without treatment

The Guardian - Pharmaceutical Industry

JULY 6, 2025

One drug, elamipretide, garnered a narrow recommendation from independent advisers for the US Food and Drug Administration (FDA), but the agency rejected the drug’s application in May and recommended another potential pathway for approval. Continue reading.

FDA

Q&A: Pharmacist Highlights Challenges in Vaccine Information Navigation Amid Changing Recommendations

Drug Topics

JULY 2, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Vaccines

Vaccines Immunization Compounding Communication

A Team Effort Is Needed for Inventory Management | McKesson ideaShare

Drug Topics

JULY 11, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Patient Care

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Fierce Pharma - Untitled Article

Fierce Pharma

JULY 9, 2025

The benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDA approves a new dosing regimen of the drug with an improved safety profile.

FDA

Q&A: Pharmacists Play Essential Role in Insulin Therapy Success

Drug Topics

JULY 15, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

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Q&A: Current Advancements in Insulin Delivery for Patients with Diabetes

Drug Topics

JULY 11, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Specialty Pharmacies

Specialty Pharmacies Compounding Independent Pharmacies Patient Care

Elevating Pharmacy Technicians in Community Practice

Drug Topics

JUNE 18, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Independent Pharmacies

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FDA approves Gamifant for macrophage activation syndrome in Still’s disease

Pharmafile

JUNE 30, 2025

The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg) for the treatment of macrophage activation syndrome (MAS) in adult and paediatric patients with known or suspected Still’s disease, including systemic juvenile idiopathic arthritis.

FDA

Gilead Sciences’ Yeztugo receives approval from US FDA for HIV

Pharmaceutical Technology

JUNE 19, 2025

The FDA has approved Gilead Sciences' injectable product, Yeztugo (lenacapavir), as a pre-exposure prophylaxis (PrEP) against HIV.

FDA

CGM Usage Improves Glycemic, Psychosocial Outcomes for Type 1 Diabetes | ADA 2025

Drug Topics

JUNE 23, 2025

Dapagliflozin Improves Health Outcomes for Adolescents With Type 1 Diabetes Ashley Gallagher June 19th 2025 Article The drug could also reduce chronic kidney disease when combined with insulin therapy.

Compounding

Compounding Specialty Pharmacies Independent Pharmacies Immunization

State-Level PBM Reform Vital for Community Pharmacies, Patient Access

Drug Topics

JULY 1, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Community Pharmacies

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Gaps Remain in MOUD Access Across Opioid Treatment Programs

Drug Topics

JUNE 30, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Compounding

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FDA clears new, safer regimen for Lilly's Alzheimer's drug

pharmaphorum

JULY 9, 2025

Eli Lilly has won FDA approval for a new regimen for its Alzheimer's disease therapy Kisunla, which carries a reduced risk of side effects

FDA

FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.

FDA

FDA Packaging Communication Hospitals

Journavx From Vertex Pharmaceuticals Inc

Pharmacy Times

JUNE 24, 2025

Suzetrigine, a new nonopioid pain reliever, gains FDA approval for treating moderate to severe acute pain in adults, offering a safer alternative to opioids.

FDA

Pharmacy Schools Should Prepare Students for Workforce Challenges

Drug Topics

JULY 9, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Health and Personal Care Stores

Health and Personal Care Stores Independent Pharmacies Compounding Specialty Pharmacies

Q&A: How Technician Fatigue Threatens Patient Safety, Care

Drug Topics

JULY 1, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Health and Personal Care Stores

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AI Generated Marketing Campaigns: Is Pharma Ready?

Pharma Marketing Network

JUNE 19, 2025

However, these benefits come with risks: Compliance pitfalls : AI-generated content must meet FDA regulations, including fair balance and risk disclosure. Any use of AI must comply with guidelines from agencies like the FDA, EMA, and FTC. Are AI campaigns compliant with FDA rules? FAQs What is an AI generated marketing campaign?

HIPAA

HIPAA FDA

Passport to Protection: Best Practices for Travel Vaccines in the Pharmacy Setting

Drug Topics

JUNE 6, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Vaccines

Vaccines Immunization Compounding Specialty Pharmacies

A biopharma doubles down on diversity goals through a newly created position

PharmaVoice

JULY 1, 2025

To help close that gap, patients stood up to tell their own stories during open, public portions of an FDA advisory committee meeting for the approval of one of Ardelyx’s drugs. That stole the day because they told us and the FDA why there was a need in this space,” she said. “In

FDA

Digital Connections Help Attract, Retain Patients in Competitive Pharmacy Landscape | McKesson ideaShare

Drug Topics

JULY 10, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Independent Pharmacies

Independent Pharmacies Patient Care Compounding Specialty Pharmacies

Q&A: How Advancements in GLP-1s, CGM Impact Insulin Management

Drug Topics

JULY 15, 2025

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy (..)

Insurance Coverage

Insurance Coverage Specialty Pharmacies Compounding Hospitals

Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

Pharmacy Times

JUNE 20, 2025

Related Videos Related Content Advertisement June 20th 2025 FDA Approves Dupilumb for Treatment of Bullous Pemphigoid Aislinn Antrim, Managing Editor May 28th 2025 Pharmacy Focus: Navigating Seasonal Allergies Luke Halpern, Assistant Editor Derek Webb, PharmD June 20th 2025 Self-Care Measures for Preventing and Managing Dysmenorrhea Yvette C.

Vaccines

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FDA Approves Nitisinone for Treatment of Alkaptonuria

FDA Approves Widaplik for Treatment of Hypertension

Trending Sources

Experts Weigh In on What FDA's Removal of REMS for CAR T Means for Patients, Pharmacists

FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency

Eli Lilly Adds Highest Doses of Zepbound to Online Pharmacy Platform

FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted

Key Differences Between FDA-Approved RSV Vaccines

FDA loosens restrictions on first-gen CAR-T therapies

FDA grants orphan drug designation to antibody-mediated rejection treatment

FDA approves Widaplik for hypertension

TikTok Videos on IBD Provide Low Quality Information

FDA Approves Linvoseltamab-Gcpt for Treatment of Relapsed or Refractory Multiple Myeloma

Independent Pharmacists’ Unique Role During Disaster Management Efforts

Guiding Patients Through Allergy Medication Safety: Pharmacists’ Role Following FDA Warning on Cetirizine and Levocetirizine

Mark Cuban Cost Plus Drugs, 9amHealth Collaborate to Make Obesity Medications Affordable

Q&A: Expert Highlights Importance of Trusted Sources for Vaccine Information

Pharmacist Involvement Helps Reduce Time to A1c Target

GLP-1s Effective as Adjunctive Therapy in Patients with T1D, Obesity | ADA 2025

Riliprubart Receives FDA Orphan Drug Designation for AMR in Solid Organ Transplantation

Patients with ultra-rare diseases worry new FDA rules will leave them without treatment

Q&A: Pharmacist Highlights Challenges in Vaccine Information Navigation Amid Changing Recommendations

A Team Effort Is Needed for Inventory Management | McKesson ideaShare

Fierce Pharma - Untitled Article

Q&A: Pharmacists Play Essential Role in Insulin Therapy Success

Q&A: Current Advancements in Insulin Delivery for Patients with Diabetes

Elevating Pharmacy Technicians in Community Practice

FDA approves Gamifant for macrophage activation syndrome in Still’s disease

Gilead Sciences’ Yeztugo receives approval from US FDA for HIV

CGM Usage Improves Glycemic, Psychosocial Outcomes for Type 1 Diabetes | ADA 2025

State-Level PBM Reform Vital for Community Pharmacies, Patient Access

Gaps Remain in MOUD Access Across Opioid Treatment Programs

FDA clears new, safer regimen for Lilly's Alzheimer's drug

FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

Journavx From Vertex Pharmaceuticals Inc

Pharmacy Schools Should Prepare Students for Workforce Challenges

Q&A: How Technician Fatigue Threatens Patient Safety, Care

AI Generated Marketing Campaigns: Is Pharma Ready?

Passport to Protection: Best Practices for Travel Vaccines in the Pharmacy Setting

A biopharma doubles down on diversity goals through a newly created position

Digital Connections Help Attract, Retain Patients in Competitive Pharmacy Landscape | McKesson ideaShare

Q&A: How Advancements in GLP-1s, CGM Impact Insulin Management

Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

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