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Follow FDA guidelines on advertising to ensure your messaging is accurate and ethical. Develop blogs, whitepapers, and videos that educate and engage. Follow FDA guidelines, ensure accurate messaging, and work closely with legal and regulatory teams to review campaigns. Disclaimer: This content is not medical advice.
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.
For example, tracking a user’s journey from a search ad to a whitepaper download offers valuable insight into funnel behavior. These formats not only engage users but also comply with FDA guidance when properly developed. These are ideal for promoting CME courses, whitepapers, and clinical trial updates.
Regulatory Constraints HIPAA, GDPR, and FDA guidelines shape how leads are collected, stored, and contacted. Webinars, whitepapers, and CME resources are particularly effective. Use clear opt-ins, partner with HIPAA-compliant vendors, and consult regulatory affairs to ensure all outreach meets FDA and GDPR standards.
Educational webinars, whitepapers, and digital reprints are performing well, especially when endorsed by credible experts. All messaging must also go through MLR (medical, legal, and regulatory) review to ensure it aligns with FDA guidelines. Content quality is also essential.
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.
Johnson & Johnson (J&J) has submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for its oral peptide, icotrokinra, to treat moderate to severe plaque psoriasis (PsO) in adults and children aged 12 years and above. Credit: design_cam/Shutterstock.com.
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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.
Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Credit: Volha_R/Shutterstock.
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Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma. Credit: Saiful52 / Shutterstock.
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The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema (HAE) in adults and in children aged 12 years and above. Credit: KalVista Pharmaceuticals/Business Wire.
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The first tranche will be received by Revolution, following US Food and Drug Administration (FDA) approval of daraxonrasib to treat metastatic PDAC by January 2028. The debt facility portion consists of three tranches totalling up to $750m linked directly to daraxonrasib’s commercial milestones.
Syngene’s expertise in the field is covered in this whitepaper. Syngene’s expertise in the field is covered in this whitepaper. You will receive an email shortly. Please check your inbox to download the Whitepaper. You will receive an email shortly. Please check your inbox to download the Whitepaper.
Madrigal accessed a large US market when it won accelerated US Food and Drug Administration (FDA) approval in March 2024 for the first MASH treatment in the region. Rezdiffra is already available in the US for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
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Transcend Therapeutics has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to TSND-201, a rapid-acting neuroplastogen, for the treatment of post-traumatic stress disorder (PTSD). Credit: Andrey_Popov/Shutterstock. Stay proactive with real-time data and expert analysis.
The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026.
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Last month, the FDA approved the Lumipulse G test , the first blood test to help diagnose the disease.
US market provides uptake hint The US Food and Drug Administration (FDA) approved Alyftrek in December 2024 , providing a window into market dynamics for the drug. With this approval, we are one step closer to our ultimate goal of restoring normal levels of CFTR function in people living with cystic fibrosis.”
In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024. How will RFK Jr’s American dream for vaccines play out? Credit: Tada Images/Shutterstock.
Ogsiveo (nirogacestat) is approved by the Food and Drug Administration (FDA) for adults with progressing desmoid tumours requiring systemic treatment. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also recommended its approval in June 2025.
Find out more The transaction will enhance Merck’s cardio-pulmonary pipeline and portfolio with the addition of Ohtuvayre (ensifentrine), an FDA-approved treatment for chronic obstructive pulmonary disease (COPD) in adults. Credit: Merck & Co.,
Image credit: Thanos Psimidis / Arena International With the US Food and Drug Administration (FDA) shifting its clinical trial regulations in recent years, working closely with regulators at the early stages of trial design is becoming increasingly important for successfully executing an oncology trial.
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How will RFK Jr’s American dream for vaccines play out? of equity shares from JB employees at the same price per share as offered to KKR. of equity shares from JB employees at the same price per share as offered to KKR.
Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook BIO President John Crowley [L] speaking to US FDA Commissioner Dr Marty Makary [R] at the BIO International Convention in Boston. Data Insights The gold standard of business intelligence.
The US Food and Drug Administration (FDA) has created a new priority review voucher (PRV) framework to expedite the drug approval process for pharma companies prioritising US interests. Credit: voffka23 via Shutterstock.
Syngene’s expertise in the field is covered in this whitepaper. Syngene’s expertise in the field is covered in this whitepaper. You will receive an email shortly. Please check your inbox to download the Whitepaper. Go deeper with GlobalData Reports LOA and PTSR Model - CDK-002 in Head And Neck Cancer Squamous Cell.
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