This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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.
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.
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.
The MHRA has recognised that some practices are better with more flexibility, and that in a technology-enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety. We may still continue to send you service-related and other non-promotional communications.
HCPs now seek scientific, outcomes-based communication—not promotional fluff. 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.
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.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Can pharma tariffs “Make America Manufacture Again”?
Another announcement made by the US Food and Drug Administration (FDA) was for an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into US patients.
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.
Annabel Kartal Allen July 31, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA has appointed George Tidmarsh as the temporary director of CBER after Vinay Prasad’s sudden exit. Image credit: -Oxford- via Getty Images. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
However, this deal was terminated by Abbot, which spun out into AbbVie in 2015, as the company decided to pursue its own JAK1 inhibitor Rinvoq (upadacitinib), which was approved in the indication by the US Food and Drug Administration (FDA) in 2019. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance. The updated ICH E6 (R3) guidelines introduce a range of critical changes aimed at modernizing clinical trials.
We may still continue to send you service-related and other non-promotional communications. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here. For more information relating to our privacy practices, we invite you to review our privacy policy. Sign up for our daily news round-up!
Meanwhile, the US Food and Drug Administration (FDA) has extended the review period for the biologics licence application (BLA) submitted by the company for Blenrep combinations for the same indication. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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.
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 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.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News MAXONA Pharma seeks FDA approval for pain relief MAX-001 MAX-001 provides both rapid onset and extended duration of analgesia. Credit: Inna Kot/Shutterstock.com.
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.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Boss points out that as far back as 1938, the uncoupler dinitrophenol saw its US Food and Drug Administration (FDA) approval withdrawn over safety concerns. Though effective in brown fat cells, he notes these are sparse among obese patients with greater numbers of white fat cells.
August 1, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The acquisition includes the FDA-approved capsules and a central nervous system discovery platform. Credit: NMK-Studio/Shutterstock.com. Supernus Pharmaceuticals has acquired Sage Therapeutics, strengthening its neuropsychiatry product portfolio.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News FDA gives accelerated approval to Jazz Pharma’s diffuse midline glioma therapy Modeyso is expected to be commercially available in late summer 2025. This is the first FDA-approved treatment for this rare and aggressive brain tumour.
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.
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.
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.”
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content