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Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.
On March 18, 2025, Drug Channels Institute will release The 2025 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. prescription drug channels. prescription drug channels. Special preorder and launch pricing discounts will be valid through March 31, 2025. All rights reserved.
2] Fitusiran was approved for medical use in the United States in March 2025. [2] 1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] 26 March 2025.
Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.
Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.
Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 1] Taletrectinib was approved for medical use in the United States in June 2025. [3] Food and Drug Administration.
1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine CAS 2649467-58-1 Weight Average: 473.4
Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] April 17, 2025. Retrieved April 18, 2025. January 2025). Hz, J HF =6.9
g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]
I am pleased to announce that Drug Channels Institutes new 2025 Economic Report on U.S. Download a free 30-page report overview including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits Read the press release: HMP Globals Drug Channels Institute Releases 2025 Economic Report on U.S.
CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.
Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Drugs/Biologics/Devices / Tobacco (CDER, CBER, CDRH, CTP) These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA). By Richard A.
4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] gmol 1 References ^ “Register of Innovative Drugs” Health Canada. 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). 25 April 2023.
Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. We also offer licenses to our secure hosted learning environmentno internal setup required! Visit our eLearning page to get started.
Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. Food and Drug Administration (FDA).
5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 16 April 2025. Retrieved 3 May 2025. Food and Drug Administration (FDA) (Press release). 29 March 2023. 24 March 2023.
Focused on Neuroimmunology in Drug Discovery, the free-to-attend forum is taking place at at MSDs (the tradename of Merck & Co., Rahway NJ USA) research facility in the Longwood medical area of Boston, Massachusetts, on 24 June 2025. The event is held in partnership with Drug Discovery News.
2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Retrieved 25 January 2025. Food and Drug Administration (FDA).
12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Retrieved 17 April 2025. January 2025.
On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.
A new roadmap for cannabis and cannabis policy research mfleming Fri, 01/03/2025 - 11:38 Nora's Blog January 14, 2025 Image Getty Images/ Fiordaliso The greatly increased availability of cannabis over the last two decades has outpaced our understanding of the public-health impacts of the drug.
Could you give us an overview of IRLAB’s current drug development pipeline? The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD. Top-line data from the Phase IIb study is expected at the beginning of 2025.
Food and Drug Administration (FDA) granted the therapy Priority Review status in May 2025 following its Biologics License Application (BLA) submission in March, reflecting the agency’s recognition of its potential to address a serious condition with limited treatment options.
Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.
Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. By Jonathan Gardner • Sept.
on June 20, 2023 and will apply starting January 1, 2025. Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. Beginning January 1, 2025, the MHRA will be responsible for authorizing all medicines for the U.K.
1] [2] [3] Levacetylleucine is the second medication approved by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease type C. [2] 2] The US Food and Drug Administration (FDA) granted the application for levacetylleucine priority review , fast track , orphan drug , and rare pediatric disease designations. [2]
The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. per share during the period from and including 27 November 2020 up to and including 27 November 2025.
Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Contrary to landiolol, exposure to other -blockers such as esmolol amplifies the re-expression of -receptors which explains the drug tolerance effect seen during long-term esmolol infusion. Jump up to: a b “Novel Drug Approvals for 2024” U.S.
Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club.
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. It will be valid until March 31, 2025. Consequently, the subsequent labeled field numbers have shifted by one.
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer.
In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.” Any CMC changes (e.g.,
Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.
Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. These include medical devices with risk Classes Is/m/r that have licenses in Canada or de novo or 510(k) clearance in the U.S. will not qualify. Notably, acceptance of the U.S. Note: The E.U.
device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K. Canada, Japan, Brazil and Australia.
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).
In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches.
The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Unlike most approved drugs, which work by turning cell signaling up or down like a dimmer switch, this approach aims to rid cells of problem proteins entirely.
FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.
As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion , above previous guidance of greater than $10 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.
Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . 5% have US Food and Drug Administration -approved treatments. The combined company is expected to deliver double-digit average annual revenue growth through 2025.
While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry.
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