FDA and Packaging - Pharmacy Technician Pulse

FDA Approves Insulin Aspart-Xjhz as First Interchangeable Biosimilar to NovoLog

Drug Topics

JULY 21, 2025

The FDA approved insulin aspart-xjhz (Kirsty) 100 units/mL as the first and only interchangeable biosimilar to insulin aspart (NovoLog). 1 The FDA approves Kirsty, an interchangeable biosimilar insulin, enhancing diabetes treatment options and accessibility for patients. Kirsty [package insert]. News release. Biocon Biologics.

FDA

FDA Specialty Pharmacies Compounding Hospitals

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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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. RELATED: Normal blood pressure levels What are the side effects of Widaplik? When will Widaplik be available?

FDA

FDA Packaging Dosage

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

Drug Topics

JULY 10, 2025

Dispensing data can also help identify patients who are good candidates for pharmacogenomic testing, for packaging services for pharmacy care at home, and even weight loss programs. By keeping the patient at top of mind and prioritizing this engagement, reviews are also becoming a more essential part of driving traffic to the pharmacy.

Independent Pharmacies

Independent Pharmacies Patient Care Compounding Specialty Pharmacies

What is compounded semaglutide made of?

The Checkup by Singlecare

JANUARY 9, 2025

Food and Drug Administration (FDA). Why and when semaglutide is compounded According to the FDA, compounded drugs are made by licensed pharmacists (or under the supervision of pharmacists in outsourcing facilities) who combine, mix, or alter ingredients of a drug. There are a few times when compounding is necessary.

Compounding

Compounding Compounding Pharmacies FDA Sterile Compounds

Five Interesting Things To Know About Sulopenem (Orlynvah)

IDStewardship

JANUARY 13, 2025

The package insert for sulopenem recommends taking it with food to maximize bioavailability. In case you are wondering, the FDA label does not list any hepatic dose adjustments. Orlynvah [package insert]. Its oral bioavailability is 40% when taken without food and increases to 64% when consumed with a high-fat meal.

Packaging

Packaging Labelling FDA

Regeneron hit with CRL following FDA inspection of Catalent site acquired by Novo Nordisk

Pharma Manufacturing

AUGUST 4, 2025

The Bloomington, Indiana facility is a fill-finish site for Regeneron’s Eylea HD and odronextamab and handles the final stages of drug preparation and packaging.

Packaging

Packaging FDA

Insmed wins FDA approval for future blockbuster Brinsupri

Pharmaceutical Technology

AUGUST 13, 2025

Buy Reports Newsletters PT News Insmed wins FDA approval for future blockbuster Brinsupri Brinsupri becomes the first bronchiectasis therapy while ushering in a new class of DPP1 inhibitors. Brinsupri has been approved to treat adults and children aged 12 years and over with NCFB. Give your business an edge with our leading industry insights.

FDA

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Does Mounjaro need to be refrigerated?

The Checkup by Singlecare

DECEMBER 17, 2024

Like semaglutide, Mounjaro (tirzepatide) is a once-a-week injectable medication that is FDA approved for helping manage blood sugar levels in those with Type 2 diabetes. It mimics two gastrointestinal hormones: glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP).

Packaging

Packaging 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

10 Innovative Trends in Pharma Marketing: Strategies for Industry Success in 2025

Pharma Marketing Network

DECEMBER 4, 2024

Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries. From eco-friendly packaging to socially responsible campaigns, sustainability resonates with today’s consumers. Navigating these requires a fine balance between creativity and compliance.

Communication

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FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer

Pharmaceutical Technology

AUGUST 11, 2025

Buy Reports Newsletters PT News FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer Vepdegestrant is an investigational, oral bioavailable PROteolysis TArgeting Chimera (PROTAC) medication. Credit: Gorodenkoff/Shutterstock.com. Give your business an edge with our leading industry insights.

FDA

FDA Packaging Communication Hospitals

What are the Top Pharma Podcasts in 2025?

Pharma Marketing Network

JUNE 14, 2025

Imagine being able to stay current on biotech breakthroughs, FDA approvals, and digital health trends—all while commuting or walking your dog. The BioPharma Brief” Hosted by scientists-turned-communicators, this podcast delivers news on late-stage trials, FDA activity, and biotech investments.

Communication

Communication FDA Packaging Labelling

C-suite shuffles ripple through pharma

PharmaVoice

JULY 31, 2025

While the company touted Perry’s 30 years of leadership in consumer packaged goods, it said an executive search firm has been hired to lead the quest for its next permanent CEO. Jazz sings new tune with CEO switch Jazz Pharmaceuticals made history by scoring the first FDA approval for a CBD-based drug in 2018.

FDA

FDA Packaging Compounding Insurance

The key role of GMP analytical testing for drug products

European Pharmaceutical Review

APRIL 4, 2025

One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). Additionally, FDA readiness has been established through a proactive external assessment of quality systems. Any identified gaps have been addressed.

Dosage

Dosage Packaging FDA Communication

Help Turn Occasional Shoppers into Loyal Customers by Investing in the Front End

Drug Topics

JULY 10, 2025

4 Stocking eco-conscious products, such as items with recyclable packaging or low-waste formulations, can help your customers meet their sustainability goals while strengthening their connection to your brand.

Health and Personal Care Stores

Health and Personal Care Stores Independent Pharmacies Labelling Specialty Pharmacies

Ascendis Pharma’s Skytrofa gains FDA approval for growth hormone deficiency

Pharmaceutical Technology

JULY 29, 2025

The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH), a prodrug of somatropin or human growth hormone (HGH), to treat adults with growth hormone deficiency (GHD). Credit: Andrei Kuzmik / Shutterstock.com. Sign up for our daily news round-up!

FDA

FDA Packaging Labelling Communication

How to deal with a drug recall in pharmacy

SingleCare

JULY 7, 2022

To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs. However, in many cases, the FDA requests or mandates that a drug is recalled.

Documentation

Documentation FDA Labelling Packaging

Flow state: The evolving shape of continuous manufacturing

Pharma Manufacturing

JUNE 17, 2025

Despite the potential efficiencies and the FDA encouraging manufacturers to make the switch from batch processing, the pharmaceutical industry has been slow to adopt continuous manufacturing due in large part to general conservatism and the cost implications of such investments. “Those are through the FDA,” he said.

Dosage

Dosage FDA Packaging

Pharma Marketing Software Roundup

Pharma Marketing Network

AUGUST 13, 2025

These tools offer features like MLR review workflows, audit trails, version control, and automated approval systems to meet FDA and HIPAA standards. Many vendors offer modular pricing and tailored packages for small to mid-size pharmaceutical or biotech companies. Can smaller pharma companies use these tools affordably?

HIPAA

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

The FDA Law Blog

JULY 10, 2025

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

FDA

FDA Packaging Communication

UK enacts law to decentralise manufacture of personalised treatments

Pharmaceutical Technology

JULY 23, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.

Communication

Communication Hospitals Packaging Insurance

J&J seeks FDA approval for icotrokinra to treat psoriasis

Pharmaceutical Technology

JULY 22, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Credit: design_cam/Shutterstock.com. Icotrokinra was co-discovered and is currently being developed through a licensing and collaboration agreement between Protagonist and J&J.

FDA

FDA Immunization Packaging Communication

MSD receives FDA approval for Enflonsia to prevent RSV

Pharmaceutical Technology

JUNE 10, 2025

MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.

FDA

FDA Research Laboratories Communication Hospitals

3 of the year’s most notable FDA nods

PharmaVoice

JUNE 27, 2025

Despite worried hand-wringing over a potential slowdown in FDA approvals under the new administration, the agency has been giving the go-ahead to drugs at a near record-setting clip. Meanwhile, the decision-making production has come during a major upheaval inside the FDA. Please let us know if you have feedback.

FDA

FDA Vaccines Packaging Dosage

5 foods to avoid while taking Brilinta

The Checkup by Singlecare

MAY 27, 2025

The drug has been approved by the Food and Drug Administration (FDA) to reduce the risk of heart attack , stroke , and cardiovascular death in people with acute coronary syndrome (ACS) or who have recently experienced a myocardial infarction (heart attack). The good news? Theres no need to avoid other favorite beverages like coffee.

Mayo Clinic

Mayo Clinic Packaging Dosage FDA

MetrioPharm gains orphan drug status from EMA for MP1032

Pharmaceutical Technology

JULY 30, 2025

This follows the ODD granted by the US Food and Drug Administration (FDA) and highlights MP1032’s potential as a first-in-class therapy that may reduce the need for high-dose corticosteroids, which can lead to serious side effects such as growth stunting, osteoporosis and metabolic issues.

Packaging

Packaging Communication Immunization FDA

ICH Q6B for Analytics

PharmTech

JUNE 6, 2025

Eisai Wins Judgment Against Shilpa Over Sale of Lenvatinib Mesylate Generic Patrick Lavery June 2nd 2025 Article As a result of the decision, Shilpa will not be eligible to receive FDA approval for its lenvatinib mesylate generic until February 2036. Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

Dosage

Dosage Documentation Labelling FDA

Hypertension: A Silent Killer Requiring Novel Therapies

Pharmacy Times

JULY 19, 2025

A new drug application for lorundrostat is expected to be filed with the FDA in 2025. doi:10.1016/20S0140-6736(22)02034-7 Aprocitentan (Tryvio) package insert. Widaplik (telmisartan, amlodipine, indapamide) package insert. mg/d, 1 mg/d, 2 mg/d, and placebo for 12 weeks. 17 The placebo-subtracted reductions in sBP were 8.1

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Compounding Pharmacies Vaccines Immunization

DSCSA Compliance Has Arrived. Now What?

Pharmaceutical Commerce

AUGUST 14, 2025

After an 18-month “stabilization” grace period, the FDA officially started enforcing DSCSA’s full suite of final requirements—including mandatory electronic, serialized exchange of transaction information, history, and statements (T3) via EPCIS—marking the end of the informal compliance deadline from November 2023. 27, 2025, and Nov.

Documentation

Documentation FDA Hospitals Packaging

Amphastar and Anji make licence agreement for three new peptides

Pharmaceutical Technology

AUGUST 13, 2025

Give your business an edge with our leading industry insights.

Packaging

Packaging Communication Hospitals FDA

BASF Opens GMP Manufacturing Facility in Michigan

PharmTech

JUNE 19, 2025

The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. Communication between the manufacturing plant and retail stores. as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients to the biopharma and pharmaceutical industries.

Dosage

Dosage Packaging FDA Communication

Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

JULY 1, 2025

What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.

FDA

FDA Hospitals Packaging Documentation

Symbicort generic: Availability, cost, and more

The Checkup by Singlecare

AUGUST 7, 2025

This is called an authorized generic , meaning it is the exact same drug packaged without the brand name. Another generic version of Symbicort, Breyna , was approved by the FDA for production by a different manufacturer (Viatris) in March 2022. An authorized generic is usually marketed by the brand-name drug company. gm of 160/4.5

Insurance

Insurance Labelling FDA Packaging

GLP-1 roadblocks: Discontinuation rates soar as insurers clamp down

PharmaVoice

JULY 7, 2025

Company Announcements View all | Post a press release ActiGraph rebrands as Ametris to reflect expanded clinical evidence generation capabilities From Ametris June 25, 2025 Groupize.ai Launches DSai™ — AI-Powered Digital Sign-In to Modernize HCP Event Compliance in L… From Groupize.ai

Insurance

Insurance Compounding Packaging FDA

FDA Approves Immunoglobulin Formulation With Low IgA Content for Primary Immunodeficiency

Pharmacy Times

JULY 7, 2025

Takeda has informed the FDA that the manufacturing of Gammagard S/D will cease in December 2027. 1,3 According to the package insert for Gammagard Liquid ERC, it is contraindicated in patients with severe systemic hypersensitivity or anaphylactic reactions to the product.

FDA

FDA Immunization Compounding Pharmacies Hospitals

Basilea secures rights to Venatorx’s antibiotic for complicated UTIs

Pharmaceutical Technology

AUGUST 14, 2025

Ceftibuten-ledaborbactam etzadroxil is a combination of ceftibuten, a drug already approved by the US Food and Drug Administration (FDA), and Venatorx’s ledaborbactam etzadroxil. Ledaborbactam etzadroxil is the orally bioavailable prodrug of the beta-lactamase inhibitor ledaborbactam.

Hospitals

Hospitals Communication FDA Packaging

Would the Industry Survive 200% Pharma Tariffs?

Pharma Marketing Network

JULY 9, 2025

From packaging to proprietary coatings to the APIs themselves, nearly every prescription bottle represents a mosaic of global logistics. Facility construction takes years, and new suppliers must meet FDA standards before production can even begin. It takes years to build FDA-compliant manufacturing sites and onboard new suppliers.

Packaging

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FDA approves YolTech’s YOLT-101 for familial hypercholesterolemia

Pharmaceutical Technology

JUNE 9, 2025

YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

FDA

FDA Communication Hospitals Packaging

Fosun and Expedition make $645m licensing deal for respiratory drug

Pharmaceutical Technology

AUGUST 12, 2025

Give your business an edge with our leading industry insights.

Packaging

Packaging Compounding Communication Hospitals

EMA Marketing Authorization of New Drugs in June 2025

PharmaShots

JULY 22, 2025

Ongoing extension trial data showed delay in DMD progression, with median ambulation loss at 18.1 vs 15.2yrs. to advanced Liver Fibrosis Date:  Jun 19, 2025 Shots: The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. 2 CR at mFU of 21.9mos., with mDoR of 14.9mos. & & mOS of 15.5mos.

Packaging

Packaging FDA

Vutrisiran marks first silencer approved for ATTR-CM

Pharmaceutical Technology

JUNE 12, 2025

Give your business an edge with our leading industry insights.

Communication

Communication Hospitals Packaging Insurance

How to help patients avoid food poisoning

The Checkup by Singlecare

AUGUST 7, 2025

When traveling, especially internationally, the CDC and FDA encourage people to consider these tips when visiting areas with unknown water quality: Drink bottled water (if bottled water isn’t available, boiling water for at least one minute is an effective way to kill germs).

Immunization

Immunization Labelling Chemotherapy Packaging

The MEK effect on cancer — a slow and steady approach to drug resistance

PharmaVoice

JULY 8, 2025

The FDA approved the first MEK inhibitor, a melanoma drug from Novartis, in 2013. The broad mechanism allows them to target multiple tumor types, including those with RAS mutations, which are common in melanoma, pancreatic, colorectal and lung cancers.

Immunization

Immunization Chemotherapy Insurance Packaging

FDA Approves Insulin Aspart-Xjhz as First Interchangeable Biosimilar to NovoLog

Independent Pharmacists’ Unique Role During Disaster Management Efforts

Trending Sources

FDA approves Widaplik for hypertension

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

What is compounded semaglutide made of?

Five Interesting Things To Know About Sulopenem (Orlynvah)

Regeneron hit with CRL following FDA inspection of Catalent site acquired by Novo Nordisk

Insmed wins FDA approval for future blockbuster Brinsupri

Does Mounjaro need to be refrigerated?

FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

10 Innovative Trends in Pharma Marketing: Strategies for Industry Success in 2025

FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer

What are the Top Pharma Podcasts in 2025?

C-suite shuffles ripple through pharma

The key role of GMP analytical testing for drug products

Help Turn Occasional Shoppers into Loyal Customers by Investing in the Front End

Ascendis Pharma’s Skytrofa gains FDA approval for growth hormone deficiency

How to deal with a drug recall in pharmacy

Flow state: The evolving shape of continuous manufacturing

Pharma Marketing Software Roundup

Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

UK enacts law to decentralise manufacture of personalised treatments

J&J seeks FDA approval for icotrokinra to treat psoriasis

MSD receives FDA approval for Enflonsia to prevent RSV

3 of the year’s most notable FDA nods

5 foods to avoid while taking Brilinta

MetrioPharm gains orphan drug status from EMA for MP1032

ICH Q6B for Analytics

Hypertension: A Silent Killer Requiring Novel Therapies

DSCSA Compliance Has Arrived. Now What?

Amphastar and Anji make licence agreement for three new peptides

BASF Opens GMP Manufacturing Facility in Michigan

Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

Symbicort generic: Availability, cost, and more

GLP-1 roadblocks: Discontinuation rates soar as insurers clamp down

FDA Approves Immunoglobulin Formulation With Low IgA Content for Primary Immunodeficiency

Basilea secures rights to Venatorx’s antibiotic for complicated UTIs

Would the Industry Survive 200% Pharma Tariffs?

FDA approves YolTech’s YOLT-101 for familial hypercholesterolemia

Fosun and Expedition make $645m licensing deal for respiratory drug

EMA Marketing Authorization of New Drugs in June 2025

Vutrisiran marks first silencer approved for ATTR-CM

How to help patients avoid food poisoning

The MEK effect on cancer — a slow and steady approach to drug resistance

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