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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.
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). Can pharma tariffs “Make America Manufacture Again”? Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard.
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. Can pharma tariffs “Make America Manufacture Again”?
Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. In a bid to chase competitiveness, the EU is advancing its most drastic revision of pharmaceutical law in 20 years.
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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. Can pharma tariffs “Make America Manufacture Again”? If approved in Europe, Rezdiffra would have the same indication.
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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). How will RFK Jr’s American dream for vaccines play out? Credit: Andrey_Popov/Shutterstock.
The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.
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. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
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.
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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.
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. Give your business an edge with our leading industry insights.
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. How will RFK Jr’s American dream for vaccines play out? Credit: Merck & Co.,
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. Can pharma tariffs “Make America Manufacture Again”? 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. The PRV programme for rare paediatric diseases, signed into law in 2012, expired in late 2024 after it failed to make it into a US Congress funding package.
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The US Food and Drug Administration (FDA) approved Yeztugo last month , bringing a more convenient PrEP option for adults and adolescents at risk of HIV exposure. The Elton John AIDS Foundation said it was “pleased to hear about the FDA approval of lenacapavir as a new and extremely effective prevention technology for HIV transmission”.
The US Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) requirements for all approved autologous chimeric antigen receptor (CAR-T) cell immunotherapies, saying the access barrier is no longer needed for the modality. How will RFK Jr’s American dream for vaccines play out?
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A shortage of a commercially available drug is one of the criteria that allows compounded production, according to US Food and Drug Administration (FDA) legislation. By GlobalData Learn more about Strategic Intelligence The FDA declared the Wegovy shortage over in April, however, signalling a boost to Novo Nordisk’s market prospects.
The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for review to treat adults with virologically suppressed human immunodeficiency virus (HIV)-1. How will RFK Jr’s American dream for vaccines play out? Credit: ktsdesign/Shutterstock. Sign up for our daily news round-up!
Regeneron has won US Food and Drug Administration (FDA) approval for Lynozyfic (linvoseltamab-gcpt), marking the entry of another BCMAxCD3 bispecific drug in the multiple myeloma (MM) treatment space. How will RFK Jr’s American dream for vaccines play out? Credit: lev radin via Shutterstock.
It’s been a busy month for Gilead, with the US Food and Drug Administration (FDA) approving the company’s injectable pre-exposure prophylaxis (PrEP) for HIV product Yeztugo (lenacapavir). Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.
All pharma shipments must meet strict regulatory requirements that vary significantly between countries, for example Good Manufacturing Practice (GMP) guidelines, which are enforced by entities such as the FDA in the US. Can pharma tariffs “Make America Manufacture Again”?
AbbVie’s purchase comes just a few days after the US Food and Drug Administration (FDA) removed an access barrier for currently approved CAR-T therapies, regarded as a boost to the sector’s outlook. CPTX2309 is built on Capstan’s targeted LNP platform to enable in vivo delivery of RNA payloads to target cells.
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Trials intended for FDA submission must include patients representative of the US population While clinical trials can be conducted in multiple regions throughout the world in order to increase the pool of eligible patients, the proportion of US patients in applications submitted to the US FDA has been declining.
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