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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

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

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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.

FDA

FDA Packaging Labelling 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.

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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.

FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

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

Trending Sources

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

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

MetrioPharm gains orphan drug status from EMA for MP1032

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

Vutrisiran marks first silencer approved for ATTR-CM

FDA approves YolTech’s YOLT-101 for familial hypercholesterolemia

Mosanna Therapeutics gains $80m to advance OSA nasal spray

Alfasigma sets stage for Jyseleca in axSpA after Phase III win

George Tidmarsh to sub in as FDA CBER head following Prasad’s shock exit

Tisento’s MELAS treatment receives fast track status from FDA

Fangzhou and Novo Nordisk link on chronic disease management

Sanofi concludes Blueprint Medicines acquisition

GSK’s Blenrep combos approved for multiple myeloma in EU

European pharma needs scalable models to succeed in US

Sartorius to invest $3m for minority share in biotech start-up Nanotein

Janssen’s Darzalex new indication gains EC approval for SMM

AstraZeneca announces $50bn US investment plans by 2030

Revolution Medicines partners Royalty Pharma on $2bn funding

How ICH E6 (R3) is changing clinical trials

EU’s Pharma Package falls short of Europe’s goal of global competitiveness

Big pharma braces for revenue headwinds as patent expiries loom

FDA approves KalVista’s Ekterly for hereditary angioedema

FDA approves label updates for BMS’ CAR T cell therapies

MAXONA Pharma seeks FDA approval for pain relief MAX-001

Actio gains $66m to advance small molecule therapeutics pipeline

GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Piramal Pharma announces $90m investment to expand US sites

EpiPen patent expiry opens new era for innovation

Supernus strengthens neuropsychiatric portfolio with Sage Therapeutics

Targeting energy expenditure: the next wave of obesity drugs

Madrigal poised to enter European MASH market after CHMP endorsement

FDA gives accelerated approval to Jazz Pharma’s diffuse midline glioma therapy

FDA gives TSND-201 breakthrough therapy designation for PTSD

Vertex wins European approval for Alyftrek, bolstering cystic fibrosis stronghold

FDA publishes more than 200 archived CRLs for transparency

Cell and gene therapy market outlook strong despite technical challenges

Gilead wins positive European approval opinion for twice-yearly HIV injection

Merck concludes SpringWorks acquisition for $3.4bn

EC approves Jazz Pharmaceuticals’ Ziihera for biliary tract cancer

CTO East Coast 2025: Navigating shifting regulatory environment hinges on close alignment

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