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Parental vaccine hesitancy, fueled by misinformation and logistical barriers, contributes to lower immunization rates and increased exemption rates. Parental vaccine hesitancy, fueled by misinformation and logistical barriers, contributes to lower immunization rates and increased exemption rates.
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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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.
How will RFK Jr’s American dream for vaccines play out? 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.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News EpiPen patent expiry opens new era for innovation The expiration of Viatris’s EpiPen patent in September 2025 will likely result in increased competition and lower costs in the epinephrine delivery space.
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.
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.
How will RFK Jr’s American dream for vaccines play out? 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.
How will RFK Jr’s American dream for vaccines play out? 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? 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. Credit: Tada Images/Shutterstock.
Twice-yearly injectable lenacapavir has already been approved in the US , with the Food and Drug Administration (FDA) approving the medicine last month. The WHO adds that the vaccine offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options.
How will RFK Jr’s American dream for vaccines play out? Ogsiveo (nirogacestat) is approved by the Food and Drug Administration (FDA) for adults with progressing desmoid tumours requiring systemic treatment.
How will RFK Jr’s American dream for vaccines play out? 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.,
How will RFK Jr’s American dream for vaccines play out? Ross Law July 9, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The panel discussed topics around regulation changes in oncology research.
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.
July 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The companies aim to gain insights that could contribute information towards designing more vaccines. Credit: Sergii Sobolevskyi/Shutterstock.com.
How will RFK Jr’s American dream for vaccines play out? The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. Credit: HenadziPechan/Shutterstock.
How will RFK Jr’s American dream for vaccines play out? 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. Go deeper with GlobalData Reports LOA and PTSR Model - BRII-732 in Human Immunodeficiency Virus (HIV).
July 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The acquisition includes vaccine candidates for respiratory syncytial virus and human metapneumovirus. EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices?
How will RFK Jr’s American dream for vaccines play out? 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.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News Uncertainty looms over FDA scheme to boost US manufacturing The FDA’s new PreCheck programme is aimed at facilitating the introduction of new US drug manufacturing facilities. sakurai5 via Shutterstock.com.
How will RFK Jr’s American dream for vaccines play out? 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. Credit: ktsdesign/Shutterstock.
How will RFK Jr’s American dream for vaccines play out? 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. Credit: lev radin via Shutterstock.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News Epkinly breaks ground in Phase III FL trial While Epkinly is approved in third-line follicle lymphoma, its success in the second-line setting is pertinent. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
How will RFK Jr’s American dream for vaccines play out? While FDA may accept clinical data from ex-US sites, the enrolled population has to be applicable to the US population and medical practice.
How will RFK Jr’s American dream for vaccines play out? 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 made up of an anti-CD19 CAR mRNA payload inside an LNP.
How will RFK Jr’s American dream for vaccines play out? For gene therapy in the US, there are eight FDA-approved oncologic treatments, with prices ranging from $65,000 to $475,000. In Europe, the cost of CAR-T cell treatment varies by country , with the average ranging from $55,000 to $450,000. However, costs can soar even higher.
How will RFK Jr’s American dream for vaccines play out? 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.
Find out more The transaction will see BioNTech assimilate its former rival in the Covid-19 vaccine arena. By GlobalData Learn more about Strategic Intelligence In July 2024, CureVac streamlined its focus towards oncology after selling influenza and Covid-19 vaccine development to GSK in a deal worth nearly €1.5bn.
Robert Barrie July 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Prasad, an oncologist who was a fierce critic of the Covid-19 vaccine response in the US, was appointed only three months ago. Marvin Joseph/The Washington Post via Getty Images.
The US Food and Drug Administration (FDA) has placed a clinical hold on several of Gilead’s trials evaluating two HIV treatment candidates, though the rest of the drugmaker’s diverse pipeline remains unaffected. Stay proactive with real-time data and expert analysis.
How will RFK Jr’s American dream for vaccines play out? GSK’s plan to bring blood cancer drug Blenrep (belantamab mafodotin) back to markets has hit a stumbling block, after the US Food and Drug Administration (FDA) identified eye safety concerns ahead of a meeting to discuss the therapy’s benefit-risk ratio.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News CorMedix signs agreement to acquire Melinta for $300m The acquisition entails royalties from US net sales of both Rezzayo and Minocin.
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