FDA Delays Drug Supply Chain Security Act Deadline Until November 2024
Drug Topics
AUGUST 25, 2023
The new deadline to be in compliance with the requirements will be November 27, 2024.
FDA Roundup: Agency Highlights from August 2024
Drug Topics
AUGUST 30, 2024
Checkout these important FDA updates from the month of August 2024.
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FDA Roundup: Agency Highlights from July 2024
Drug Topics
JULY 26, 2024
Check out these important FDA updates from the month of July 2024.
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FDA Roundup: Drug Approvals From April 2024
Drug Topics
APRIL 29, 2024
Check out these important FDA updates from the month of April 2024.
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STAT+: 3 FDA staffers to watch in 2024
STAT
DECEMBER 27, 2023
WASHINGTON — The Food and Drug Administration has a lot on its plate in 2024 with the reorganizations of its food center and the office that inspects FDA-regulated facilities. Amid that massive reorganization, the FDA also will lose one of its most influential leaders.
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FDA Roundup: Agency Highlights from September 2024
Drug Topics
SEPTEMBER 27, 2024
Check out these important FDA updates from the month of September 2024.
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FDA Roundup: Drug Approvals From May 2024
Drug Topics
MAY 31, 2024
Check out these important FDA updates from the month of May 2024.
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COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
Drug Topics
AUGUST 22, 2024
Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.
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Breaking: FDA Clears Dexcom Stelo, First OTC Continuous Glucose Monitor
Drug Topics
MARCH 5, 2024
Dexcom's Stelo will be available in summer 2024.
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FDA Approves Onyda XR, First and Only Liquid Nonstimulant for ADHD
Drug Topics
MAY 30, 2024
The drug will be available in pharmacies during the second half of 2024.
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JPM: Four ways FDA is seeking to buoy gene therapy
pharmaphorum
JANUARY 8, 2024
Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research told a packed house in San Francisco for JPM that FDA wants to support gene therapies in 2024.
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FDA Approves Selarsdi as Biosimlar to Stelara in an Intravenous Formulation
Pharmacy Times
OCTOBER 22, 2024
In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
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FDA Announces Delayed Enforcement of DSCSA to 2024
Pharmacy Times
AUGUST 28, 2023
The start date of the package-level electronic tracking system will shift from November 27, 2023 to November 27, 2024.
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ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission
Fierce Pharma
AUGUST 30, 2024
ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission fkansteiner Fri, 08/30/2024 - 15:54
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FDA Roundup: Agency Highlights from October 2024
Drug Topics
NOVEMBER 1, 2024
Check out these important FDA updates from the month of October 2024.
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FDA Roundup: Agency Highlights From June 2024
Drug Topics
JUNE 28, 2024
Check out these important FDA updates from the month of June 2024.
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FDA: Roflumilast Cream sNDA Accepted for Atopic Dermatitis
Drug Topics
NOVEMBER 29, 2023
The treatment from Arcutis Biotherapeutics has a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2024.
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Biotech layoffs, slumping stocks, and a 2024 preview
STAT
JANUARY 18, 2024
And what’s going to move markets in 2024? We also look ahead to the biggest biotech stories coming in 2024, including some major data readouts and a few pivotal FDA decisions. Why are rich biotechs cutting costs? Has JPM Week already worn off? Read the rest…
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FDA approval numbers soar after COVID troubles
pharmaphorum
JANUARY 31, 2024
FDA approval numbers soar after COVID troubles Mike.Hammerton Wed, 31/01/2024 - 12:00 Bookmark this
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FDA releases roster of digital health advisory committee, chaired by American College of Cardiology innovation officer
Fierce Healthcare
AUGUST 6, 2024
FDA releases roster of digital health advisory committee, chaired by American College of Cardiology innovation officer ebeavins Tue, 08/06/2024 - 10:26
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FDA to Create Digital Health Advisory Committee By 2024
Pharmacy Times
OCTOBER 17, 2023
The committee will help the FDA address issues related to digital health technologies, including artificial intelligence, virtual reality, cyber security, and patient-generated health data.
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FDA advisory panel recommends a streamlined flu vaccine for next fall
STAT
MARCH 5, 2024
Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so. Read the rest…
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FDA Clears Wearable Insulin Delivery Device Omnipod GO for Type-2 Diabetes
Drug Topics
APRIL 27, 2023
Insulet plans to commercialize the new product in the United States starting in 2024.
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Comparison Of Rebyota Versus Vowst: A Study Table To Help You Compare Fecal Microbiota Therapies
IDStewardship
APRIL 14, 2024
Article Posted 14 April 2024 What is Clostridioides difficile ? These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved.
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FDA Grants Marketing Authorization to First-Ever OTC Syphilis Test
Drug Topics
AUGUST 16, 2024
First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024.
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FDA Accepts Supplemental Biologics Applications for Nivolumab-Based Regimens for Treatment of Resectable Lung Cancer
Pharmacy Times
FEBRUARY 7, 2024
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.
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FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic
Fierce Pharma
FEBRUARY 14, 2024
FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10
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EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments
Pharmaceutical Technology
JUNE 21, 2024
Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.
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FDA issues summary of grants, promotes rare disease research
pharmaphorum
OCTOBER 2, 2024
FDA issues summary of grants, promotes rare disease research Nicole.Raleigh Wed, 02/10/2024 - 08:20 Bookmark this
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Ready-to-Use Phosphorus Solution From Amneal Pharmaceuticals Wins FDA Approval
Drug Topics
JULY 30, 2024
The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter.
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Viatris' launch plans scuttled as FDA rebuffs long-acting MS drug from partner Mapi
Fierce Pharma
MARCH 11, 2024
Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Co | Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s (..)
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FDA expert panel endorses idea of removing a component from flu vaccine
STAT
OCTOBER 5, 2023
The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline.
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FDA reveals diversity action plan guide for clinical trials
pharmaphorum
JUNE 27, 2024
FDA reveals diversity action plan guide for clinical trials Phil.Taylor Thu, 27/06/2024 - 09:11 Bookmark this
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Analytica 2024 in overview
European Pharmaceutical Review
MARCH 5, 2024
International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. analytica 2024 provides a comprehensive overview of innovative analytics and molecular – as well as microbiological – testing methods. Top topics at the trade fair include digitalisation, Laboratory 4.0,
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New COVID-19 jabs approved by FDA for 2024-25 season
pharmaphorum
AUGUST 23, 2024
The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2
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FDA Clears First OTC Continuous Glucose Monitoring, Dexcom Stelo Glucose Biosensor System
Pharmacy Times
MARCH 5, 2024
The continuous glucose monitoring system will be available for purchase online and without a prescription starting in summer 2024.
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FDA allows Florida to import drugs from Canada
The Checkup by Singlecare
JANUARY 19, 2024
Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier? an outlier?
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FDA Approves Ceftobiprole Medocaril Sodium for 3 Indications
Drug Topics
OCTOBER 14, 2024
The FDA approved ceftobiprole medocaril sodium for injection (Zevtera) in April 2024.
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FDA approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine
Pharmaceutical Technology
SEPTEMBER 12, 2023
The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.
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HDA 2023 Traceability Seminar: An FDA DSCSA Overview
Pharmaceutical Commerce
AUGUST 30, 2023
Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.
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With expanded FDA nod for RSV shot Abrysvo, Pfizer gains edge on GSK's Arexvy. But will it amount to much?
Fierce Pharma
OCTOBER 23, 2024
With expanded FDA nod for RSV shot Abrysvo, Pfizer gains edge on GSK's Arexvy. kdunleavy Wed, 10/23/2024 - 10:09 But will it amount to much?
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CHMP meeting highlights: April 2024
European Pharmaceutical Review
APRIL 30, 2024
Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. CHMP meeting highlights: March 2024 The post CHMP meeting highlights: April 2024 appeared first on European Pharmaceutical Review.
Preview the New Medications of 2024
OctariusRx
JULY 8, 2024
Preview the new medications of 2024, as we reach the halfway point of the year. Food and Drug Administration (FDA) is constantly reviewing and approving new medications and the number of medications approved in recent years has drastically increased. The post Preview the New Medications of 2024 appeared first on OctariusRX.
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FDA Aligns with Pharmacists in Ensuring Integrity of Drug Supply Chain | ASPL 2024
Drug Topics
NOVEMBER 13, 2024
An FDA representative gave a presentation on her organization’s recent updates regarding drug supply chain rules and regulations.
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