Drug Topics

AUGUST 22, 2024

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

Vaccines 387

Vaccines FDA 387

Drug Topics

MAY 30, 2024

The drug will be available in pharmacies during the second half of 2024.

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FDA 503

Drug Topics

NOVEMBER 1, 2024

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

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FDA 216

Drug Topics

JUNE 28, 2024

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

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FDA 216

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.

FDA 495

FDA 495

Drug Topics

MARCH 5, 2024

Dexcom's Stelo will be available in summer 2024.

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FDA 503

Drug Topics

APRIL 27, 2023

Insulet plans to commercialize the new product in the United States starting in 2024.

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FDA 469

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 407

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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FDA 281

Drug Topics

OCTOBER 14, 2024

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

FDA 247

FDA 247

Drug Topics

NOVEMBER 13, 2024

An FDA representative gave a presentation on her organization’s recent updates regarding drug supply chain rules and regulations.

FDA 247

FDA 247

The FDA Law Blog

APRIL 8, 2025

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

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FDA Documentation Labelling 144

Drug Topics

FEBRUARY 11, 2025

Tryvio was given FDA approval on March 19, 2024.

FDA 247

FDA 247

European Pharmaceutical Review

APRIL 21, 2025

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Why is the FDA’s decision to approve Dupixent as a new treatment for chronic spontaneous urticaria significant?

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FDA 105

Drug Topics

SEPTEMBER 18, 2024

The Eversense 365 is the world’s first long-term CGM that provides 1 year of use and should be available by the fourth quarter of 2024.

FDA 281

FDA 281

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.

FDA 247

FDA 247

Drug Topics

OCTOBER 2, 2024

The once-daily, extended release, oral suspension medication was approved by the FDA in May 2024.

FDA 281

FDA 281

Drug Topics

OCTOBER 15, 2024

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

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FDA 190

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.

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FDA 130

STAT

JANUARY 6, 2025

In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has received over 500 drug submissions with AI components since 2016, with a large number in the areas of oncology, neurology, and gastroenterology.  

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FDA 131

Drug Topics

OCTOBER 17, 2024

Three RSV vaccines are currently FDA approved for use in adults aged 60 or older.

Vaccines 247

Vaccines FDA 247

Drug Topics

FEBRUARY 12, 2024

The NDA submitted by Lykos Therapeutics was assigned a Prescription Drug User Fee Act date of August 11, 2024.

FDA 281

FDA 281

STAT

DECEMBER 30, 2024

  The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing.

Documentation 137

Documentation FDA 137

Drug Topics

AUGUST 13, 2024

The FDA approved imetelstat (Rytelo) in June 2024.

FDA 216

FDA 216

Drug Topics

OCTOBER 24, 2023

The Omnipod 5 app from Insulet lets users sync their data in one interface and is expected to be released sometime in 2024.

FDA 247

FDA 247

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

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.

FDA 144

FDA 144

STAT

NOVEMBER 8, 2024

However, the FDA action is only related to orally administered phenylephrine and not the nasal spray form. Last year, an FDA advisory panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.

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FDA 99

Drug Topics

NOVEMBER 25, 2024

FDA approval was granted on September 13, 2024.

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FDA 190

PharmaVoice

JANUARY 8, 2024

New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

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FDA 189

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 97

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 138

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

STAT

MAY 6, 2025

By 2024, one-third of their new compounds were coming from Chinese biotechnology firms. Five years ago, U.S. pharmaceutical companies didn’t license any new drugs from China. Why are U.S. drugmakers sending their business to China?

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Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 125

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.

FDA 122

FDA 122

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 121

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 98