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Ads must include proper disclosures, balance benefit-risk information, and avoid off-label promotion. 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.
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. Credit: Utthapon wiratepsupon via 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. Credit: Volha_R/Shutterstock.
June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.
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.
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.
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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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Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.
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. MAXSHOT.PL via Shutterstock.
Abigail Beaney July 22, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Sarepta will pause shipments of the therapy to the US while it discusses the therapy with the FDA. Sarepta confirmed it will work with the FDA to respond to requests for information while advancing the Elevidys safety labelling supplement process.
With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.” How will RFK Jr’s American dream for vaccines play out?
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Comparing sales from other drugs is tricky because Spevigo is the only US Food and Drug Administration (FDA)-approved treatment specifically for GPP. By GlobalData Learn more about Strategic Intelligence LEO calls Spevigo “the flagship dermatology product” of Boehringer Ingelheim, though the drug’s sales have not been publicly disclosed.
The European approval follows a similar decision made by the US Food and Drug Administration (FDA) in March 2025. Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. Imfinzi is a major revenue driver for AstraZeneca, generating around $4.7bn in sales in 2024.
By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Sarepta stated the event has been reported to the US Food and Drug Administration (FDA) and global health authorities. Don’t let policy changes catch you off guard.
The US Food and Drug Administration (FDA) has expanded approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot will be recommended for broader use in the national immunisation schedule. WESTOCK PRODUCTIONS via Shutterstock.
July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.
Abigail Beaney July 21, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA has told Sarepta to pull the therapy and also ordered a clinical hold on another gene therapy.
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.
The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.
Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”
This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE).
In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. The drug was approved to treat type 2 diabetes mellitus in May. compared to a 5.1% reduction for people treated with semaglutide.
In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. The EMA also expanded the label of AbbVie’s Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease.
In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. The drug was approved to treat type 2 diabetes mellitus in May. compared to a 5.1% reduction for people treated with semaglutide.
Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.
As previously m entioned , sponsors can interact with FDA in the town hall by submitting questions in advance or by asking a question live during the meeting. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND. The workshop is also discussed in Cell & Gene here and here.
There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label.
This includes ensuring maturity levels for all operating model elements follow the five general maturity levels defined by the FDA: 1–Initial, 2–Developmental, 3–Defined, 4–Managed, and 5–Optimized. A main area to consider is connections, such as: Bridging industry 4.0 to a pharma-specific Pharma 4.0™ to a pharma-specific Pharma 4.0™
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.
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