Drug Topics

JUNE 28, 2024

Check out these important FDA updates from the month of June 2024.

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FDA 112

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 136

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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FDA 98

Pharmaceutical Commerce

AUGUST 28, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

FDA 59

FDA 59

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 107

Med Ed 101

OCTOBER 2, 2024

The FDA has been busy this year reviewing new medications. As a practicing pharmacist, it is hard to remember everything so I wanted to outline the top 5 drug approvals in 2024 that may impact ambulatory care and geriatrics. Without further ado, here’s my top 5 drug approvals in 2024.

FDA 59

FDA 59

Drug Topics

AUGUST 25, 2023

The new deadline to be in compliance with the requirements will be November 27, 2024.

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FDA 187

Drug Topics

OCTOBER 14, 2024

The FDA approved ceftobiprole medocaril sodium for injection (Zevtera) in April 2024.

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FDA 98

Pharmafile

NOVEMBER 8, 2023

Johnson & Johnson MedTech have announced plans to submit the Ottava robotic surgical system to the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) application in the second half of 2024. This will allow the company to move its device into US-based clinical trials in 2024.

FDA 59

FDA 59

Drug Topics

AUGUST 22, 2024

Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.

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Vaccines FDA 154

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 82

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.

FDA 98

FDA 98

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.

Packaging 122

Packaging FDA 122

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.

FDA 112

FDA 112

Fierce Pharma

OCTOBER 29, 2024

As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.

FDA 113

FDA 113

pharmaphorum

OCTOBER 2, 2024

FDA issues summary of grants, promotes rare disease research Nicole.Raleigh Wed, 02/10/2024 - 08:20 Bookmark this

FDA 110

FDA 110

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

FDA 133

FDA 133

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 122

Drug Topics

NOVEMBER 12, 2024

FDA experts gathered to discuss the DEA’s rescheduling of marijuana and how it will impact the pharmaceutical supply chain.

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FDA 98

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.

FDA 138

FDA 138

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 109

PharmaVoice

JANUARY 12, 2024

Following a year where the FDA approved 55 new drugs, the 2024 PDUFA calendar is set with a number of potentially buzzy approvals.

FDA 52

FDA 52

OctariusRx

OCTOBER 14, 2024

Drug shortages have dropped below 100 different medications, with the Food and Drug Administration (FDA) noting 95 products as being unavailable. The post Drug Shortages Update: October 2024 appeared first on OctariusRX. This week we are once again providing an update on the most recent drug shortages. Contact us for assistance.

Long-Term Care Facilities 78

Long-Term Care Facilities FDA 78

Drug Topics

OCTOBER 15, 2024

On June 26, 2024, the FDA approved ensifentrine (Ohtuvayre) for the treatment of COPD.

FDA 98

FDA 98

Pharmacy Times

AUGUST 5, 2024

In the first half of 2024, the FDA approved 23 novel drugs for conditions including alopecia areata, Alzheimer disease, small cell lung cancer, bladder cancer, and more.

FDA 50

FDA 50

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,

Labelling 98

Labelling FDA 98

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?

FDA 94

FDA 94

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

FDA 100

FDA Vaccines 100

OctariusRx

JULY 22, 2024

Drug shortages currently remain at over 100 different medications, with the Food and Drug Administration (FDA) noting 109 products as being unavailable. The post Drug Shortages Update: July 2024 appeared first on OctariusRX. This week we are once again providing an update on the most recent drug shortages. Contact us for assistance.

Long-Term Care Facilities 82

Long-Term Care Facilities FDA 82

European Pharmaceutical Review

OCTOBER 3, 2024

The post <em>European Pharmaceutical Review </em> Issue 4 2024 appeared first on European Pharmaceutical Review. Preparing for the impact of EU GMP Annex 1 on primary packaging Niamh Bissett and Dr Ana Kuschel West Pharmaceutical Services, Inc. Login or create an account to download your copy of our Issue now!

Packaging 59

Packaging Vaccines FDA 59

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.

Generic Medicine 98

Generic Medicine Chemotherapy Hospitals FDA 98

pharmaphorum

AUGUST 26, 2024

Mixed reactions among HCPs as lecanemab and donanemab secure FDA approval for Alzheimer's treatment Mike.Hammerton Mon, 26/08/2024 - 10:00 Bookmark this

FDA 92

FDA 92

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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Vaccines FDA 130

pharmaphorum

JUNE 27, 2024

FDA reveals diversity action plan guide for clinical trials Phil.Taylor Thu, 27/06/2024 - 09:11 Bookmark this

FDA 102

FDA 102

The FDA Law Blog

AUGUST 24, 2023

(“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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FDA 98

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 Dosage Insurance 105

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

FDA 119

FDA 119