2026 and Labelling - Pharmacy Technician Pulse

Development of flexible assembly and packaging line to support clinical volumes of pens, autoinjectors and safety devices used for drug delivery

PharmaVoice

JULY 21, 2025

West’s new flexible line for pens and autoinjectors, launching Q1 2026, will streamline assembly, labeling, packaging and testing for clinical volumes and drive cost efficiency.

Packaging

Packaging Labelling

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

PharmaShots

JUNE 11, 2025

Shots: The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026 Preclinical studies showed that NVC-001 significantly improved survival and cardiac function.

Labelling

Labelling FDA

New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

JUNE 27, 2025

Mary Dzhuryan is a class of 2026 PharmD candidate at the USC Alfred E. Mehrnaz Razavi Vakhshoori is a class of 2026 PharmD candidate at the USC Alfred E. The recent application was granted both priority review and orphan drug designation. Mann School of Pharmacy and Pharmaceutical Sciences in Los Angeles.

FDA

FDA Compounding Pharmacies Immunization Chemotherapy

Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

JULY 10, 2025

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.

FDA

FDA Hospitals Compounding Pharmacies Immunization

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

Pharmaceutical Technology

JULY 29, 2025

The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin.

FDA

FDA Packaging Labelling Communication

FDA to Evaluate Merck’s Doravirine, Islatravir Regimen for HIV-1

Drug Topics

JULY 10, 2025

1 The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. MK-8591A-051 is a randomized, active-controlled, open-label phase 3 study evaluating the safety, tolerability, and antiretroviral activity of a switch to doravirine/islatravir compared with continued baseline antiretroviral therapy.

FDA

FDA Vaccines Specialty Pharmacies Compounding

FDA approves KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

JULY 7, 2025

The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. KalVista will receive an upfront payment of $11m, with an additional $11m contingent upon achieving a regulatory milestone anticipated by early 2026. Sign up for our daily news round-up!

FDA

FDA Packaging Communication Hospitals

Vertex and NHS England agree reimbursement for Alyftrek

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

Packaging Communication Hospitals Vaccines

Health Canada extends Evkeeza approval for children with HoFH

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

Packaging Communication Hospitals Vaccines

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

JULY 14, 2025

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. A decision by the FDA is expected in H1 2026. MAXSHOT.PL via Shutterstock.

Labelling

Labelling Vaccines FDA Packaging

Sarepta halts Elevidys shipments following FDA pressure

Pharmaceutical Technology

JULY 22, 2025

It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

FDA

FDA Labelling Communication Packaging

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

Packaging Communication Hospitals Vaccines

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Pharmaceutical Technology

JULY 15, 2025

Danish dermatology leader LEO Pharma has bought the rights to Boehringer Ingelheim’s psoriasis drug Spevigo (spesolimab) for €90m ($105m), strengthening its portfolio ahead of a possible public listing in 2026.

Packaging

Packaging Communication Hospitals Vaccines

Why global 3PL providers are essential to easing supply chain challenges

Pharmaceutical Technology

JULY 16, 2025

This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. 3PLs can unlock cost savings that their customers might find harder to achieve.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging

Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

Pharmaceutical Technology

JUNE 13, 2025

By GlobalData Learn more about Strategic Intelligence Moderna said it plans to have mRESVIA available for both both younger adults and older adults in the US in time for the 2025-2026 respiratory virus season. This usually begins around November and peaks in the mid-Winter months.

Vaccines

Vaccines FDA Labelling Communication

Eli Lilly’s Mounjaro shows cardiovascular gains, but analysts underwhelmed

Pharmaceutical Technology

AUGUST 1, 2025

Eli Lilly is attempting to join fellow pharma companies with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) – drugs originally approved for treating diabetes – gaining expanded label expansions in cardiovascular indications.

Packaging

Packaging Communication Hospitals Labelling

Procedure Shows Promise for Sustained Weight Loss After GLP-1 Therapy

Drug Topics

JUNE 25, 2025

The study is an open-label cohort trial aimed at evaluating the safety, tolerability, and early efficacy of Revita for patients who lost at least 15% or more of their total body weight with a recently discontinued GLP-1. Investigators expect midpoint data in the third quarter of 2025 and 6-month data in the second half of 2026.

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Compounding Specialty Pharmacies Independent Pharmacies

Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

JULY 17, 2025

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. With its pipeline reprioritisation, the company anticipates delivering $300m in annual non-personnel cost savings from 2026.

Labelling

Labelling Communication Packaging Hospitals

Sarepta refuses to pull gene therapy despite FDA order

Pharmaceutical Technology

JULY 21, 2025

“This guides every decision we make, as evidenced by our conservative decision to pause shipments of Elevidys for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure (ALF).”

FDA

FDA Labelling Packaging Communication

Hair Loss Therapy Shows Potential for Regeneration in Phase 2 Trial

Drug Topics

JUNE 17, 2025

1 The company said it plans to initiate phase 3 studies in 2026 to further evaluate the therapy. After the randomized portion of the study, patients were eligible to enroll in an open-label extension study for 3 months to assess the long term safety of PP405.

Specialty Pharmacies

Specialty Pharmacies Compounding Independent Pharmacies Immunization

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

The FDA Law Blog

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

FDA

FDA Documentation Labelling Method Validation

EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day. billion for Blincyto.

Labelling

Labelling Communication Hospitals Vaccines

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

The FDA Law Blog

FEBRUARY 20, 2025

FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ).

FDA

FDA Labelling Communication

The Role of Electronic Labeling in Sustainable Practices

Pharmaceutical Commerce

FEBRUARY 21, 2025

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on other concepts that are powering the companys 2025 Supply Chain Trends Report, and how they could possibly change in 2026.

Labelling

Janssen leads effort to cut waste in digital health devices

pharmaphorum

OCTOBER 14, 2022

” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum.

Labelling

CD19 CAR-T agents to boost blood cancer market

European Pharmaceutical Review

FEBRUARY 8, 2023

Breyanzi is approved for DLBCL, and a label expansion is anticipated for expansions into marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) in 2026 and 2028, respectively. This allows for a large total eligible patient population despite capturing less patient share relative to other CD19 CAR-T agents.

Labelling

Labelling Compounding

WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

Packaging

Packaging Dosage Labelling

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

JULY 26, 2022

There are two branded miglustat therapies available across the 3MM, with the US market having Johnson and Johnson’s (J&J, US) Zavesca and also generic miglustat available, but neither of these are approved for the treatment of NPC, so physicians prescribe this therapy off-label.

Compounding

Compounding Labelling

FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA

FDA Labelling Packaging Documentation

Januvia generic availability, cost, and dosage

The Checkup by Singlecare

FEBRUARY 10, 2025

No generic version of Januvia is available in the United States, but this could change in 2026 when the main patent expires. The first patent, covering the dihydrogen phosphate salt of sitagliptin, expires on November 24, 2026. Polycystic ovary syndrome (PCOS) Januvia can also be prescribed off-label to treat PCOS.

Dosage

Dosage Labelling Insurance Coverage FDA

Does Medicare cover Trintellix?

The Checkup by Singlecare

AUGUST 1, 2024

holds the patent for Trintellix, which is expected to expire in 2026, when a generic version may become available. In addition, insurance plans may only provide coverage for on-label uses, which are uses approved by the FDA. As a brand-name drug, Trintellix may be more expensive than generic alternatives. Takeda Pharmaceuticals Inc.

Insurance

Insurance Mail-Order Pharmacies Insurance Coverage FDA

GSK moves further ahead in BCMA with EU okay for Blenrep

pharmaphorum

AUGUST 27, 2020

Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients who have received at least four prior therapies. billion in 2026.

FDA

FDA Labelling

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell.

FDA

FDA Labelling

Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

pharmaphorum

APRIL 23, 2021

At the moment, IgAN is controlled using blood pressure medication to limit damage to the kidney, with immunosuppressants such as corticosteroids used off-label in some cases to suppress the autoimmune response. It is usually diagnosed after patients see blood in their urine and undergo a kidney biopsy.

Labelling

Labelling Immunization

CTI wins over FDA to claim early review of myelofibrosis drug

pharmaphorum

OCTOBER 1, 2020

Undeterred, CTI argued that it should move ahead with a filing based on additional data from an open-label study called PAC203, whilst also starting another phase 3 trial – PACIFICA – to bolster the data. Shortly after, Shire (now part of Takeda) ducked out of a $172 million partnership for the drug. Jakafi had sales of more than $1.1

FDA

FDA Packaging Labelling

Brazilian federal court denies semaglutide patent extension

Pharmaceutical Technology

MAY 9, 2023

The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031). None of the three are currently publicly reimbursed.

Labelling

Labelling FDA

Ozempic for insulin resistance: What research shows

The Checkup by Singlecare

MARCH 21, 2024

These findings have spurred further research, with ongoing clinical trials set to conclude in October 2026. Always consult a healthcare provider for the appropriate dosage, and closely follow their instructions for maximum safety and effectiveness, especially if you’re using the medication off-label for a condition other than diabetes.

Dosage

Dosage Insurance Coverage Labelling Insurance

Perimenopause: Tackling the dearth of treatments for anxiety and depression

Pharmaceutical Technology

MARCH 7, 2023

Zulresso contains brexanolone, which is chemically identical to allopregnanolone, as per the drug’s label. With an estimated completion date of May 2026, the study strives to utilise the endocrine biology of perimenopause to explain the behavioural and neurobiological features of depression in perimenopausal women.

Labelling

Labelling Hospitals FDA

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

The FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.

FDA

FDA Labelling Communication

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

JANUARY 10, 2023

Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth.

Labelling

Labelling Pharmaceutical Companies Pharmaceutical Companies Compounding

DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

JULY 11, 2024

The exemption will last until November 27, 2026, for those small dispensers who qualify. On June 12, 2024, the FDA released a notice stating that it is issuing exemptions from specific requirements of the DSCSA to small pharmacies to go into effect on 11/27/2024 to ensure patient access.

Independent Pharmacies

Independent Pharmacies FDA Documentation CPhT

Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging

Packaging Labelling Documentation Dosage

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

The FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.

Labelling

Labelling Compounding Payment Processing Vaccines

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

The FDA Law Blog

JULY 7, 2024

10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] With respect to the UDI requirement, FDA regulations require them to be placed on the device “label.”

Labelling

Labelling FDA Documentation Communication

Development of flexible assembly and packaging line to support clinical volumes of pens, autoinjectors and safety devices used for drug delivery

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

Trending Sources

New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

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

FDA to Evaluate Merck’s Doravirine, Islatravir Regimen for HIV-1

FDA approves KalVista’s Ekterly for hereditary angioedema

Vertex and NHS England agree reimbursement for Alyftrek

Health Canada extends Evkeeza approval for children with HoFH

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Sarepta halts Elevidys shipments following FDA pressure

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Why global 3PL providers are essential to easing supply chain challenges

Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

Eli Lilly’s Mounjaro shows cardiovascular gains, but analysts underwhelmed

Procedure Shows Promise for Sustained Weight Loss After GLP-1 Therapy

Sarepta Therapeutics to cut 500 jobs amid restructuring

Sarepta refuses to pull gene therapy despite FDA order

Hair Loss Therapy Shows Potential for Regeneration in Phase 2 Trial

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

The Role of Electronic Labeling in Sustainable Practices

Janssen leads effort to cut waste in digital health devices

CD19 CAR-T agents to boost blood cancer market

WuXi STA breaks ground on new Delaware manufacturing facility

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

FDA Issues Long-Awaited QMSR Final Rule

Januvia generic availability, cost, and dosage

Does Medicare cover Trintellix?

GSK moves further ahead in BCMA with EU okay for Blenrep

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

CTI wins over FDA to claim early review of myelofibrosis drug

Brazilian federal court denies semaglutide patent extension

Ozempic for insulin resistance: What research shows

Perimenopause: Tackling the dearth of treatments for anxiety and depression

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

DSCSA Postponement And What It Means For Independent Pharmacies

Can holograms help in the frontline fight against pharmaceutical counterfeiting?

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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