Drug Topics

FEBRUARY 4, 2025

The drug will be made available in the second quarter of 2025.

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FDA 281

Drug Topics

SEPTEMBER 23, 2024

LEO Pharma expects the regulatory review process to be completed in the second half of 2025.

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FDA 281

Drug Topics

FEBRUARY 6, 2025

With the acceptance of the new drug application and granting priority review, the target action date is August 12, 2025.

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FDA 281

Pharma Marketing Network

APRIL 2, 2025

In 2025, the strategies that succeed are rooted in personalization, innovation, and real-time adaptability. In 2025, the ability to react to these preferences in near real time is what separates leading pharma marketing teams from the rest. FAQs What is the biggest trend in marketing in pharma in 2025?

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Communication FDA 64

The Checkup by Singlecare

MARCH 7, 2025

On March 4, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the first generic form of Xarelto (rivaroxaban), a popular anticoagulant medication. To gain FDA approval , a generic medication must be proven to work the same and provide the same benefits as the brand-name medication.

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FDA Insurance 99

Drug Topics

NOVEMBER 12, 2024

The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.

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FDA 247

Drug Topics

JULY 10, 2024

Ustekinumab-ttwe, a biosimilar to ustekinumab (Stelara) is expected launch in the US in February 2025.

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FDA 216

Drug Topics

FEBRUARY 25, 2025

The technology will be available to patients in the United States in March 2025.

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FDA 216

Drug Topics

AUGUST 12, 2024

Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.

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FDA 216

Drug Topics

OCTOBER 10, 2024

The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.

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FDA 216

Drug Topics

AUGUST 20, 2024

Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.

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FDA 216

The FDA Law Blog

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.

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Packaging Documentation Compounding 59

PharmaVoice

JANUARY 6, 2025

A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.

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FDA 215

Pharma Marketing Network

DECEMBER 4, 2024

As we approach 2025, emerging trends are reshaping how the industry engages with patients and healthcare providers. Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries. Navigating these requires a fine balance between creativity and compliance.

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Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmacy Times

SEPTEMBER 24, 2024

The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.

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FDA 123

Pharmacy Times

AUGUST 22, 2024

The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.

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FDA 123

The FDA Law Blog

MARCH 23, 2025

Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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FDA Labelling 59

Fierce Pharma

MAY 29, 2024

-first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. But thanks to a new FDA approval, the company is nearing yet another biosimilar launch.

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FDA 69

pharmaphorum

MAY 18, 2022

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.

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FDA 139

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 120

Pharmacy Times

AUGUST 20, 2024

Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.

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FDA 132

Pharmacy Times

SEPTEMBER 10, 2024

The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.

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FDA 94

STAT

DECEMBER 21, 2023

But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT. Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials.

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FDA 121

The FDA Law Blog

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

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FDA 59

Fierce Pharma

NOVEMBER 27, 2024

Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee ( | The agency's Oncologic Drugs Advisory Committee is set to discuss the treatment and its phase 3 CABINET study in March ahead of the FDA's planned (..)

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FDA 90

The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response. How much will Wezlana cost?

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FDA Immunization 110

Fierce Pharma

AUGUST 7, 2024

In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025. . | Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold.

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FDA 97

pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The post Amgen’s Soliris biosimilar clears phase 3, but won’t launch until 2025 appeared first on.

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Labelling FDA 98

Pharmaceutical Technology

JULY 31, 2024

The FDA has set a PDUFA target action date of 30 January 2025 for Vertex’s acute pain treatment therapy that is a non-opioid alternative.

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FDA 85

pharmaphorum

MARCH 14, 2025

The FDA has released its recommendations on the composition of influenza vaccines for the 2025-26 season, without the input of its external advisors

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Vaccines FDA 80

Pharmaceutical Technology

OCTOBER 1, 2024

Otulfi is the fourth Stelara biosimilar approved in the US but will not launch until early 2025.

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FDA 105

Fierce Pharma

NOVEMBER 1, 2023

The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. | The FDA has approved Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara.

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FDA 94

pharmaphorum

FEBRUARY 27, 2025

An FDA advisory committee due to be held in March to discuss the formulation of influenza vaccines for the 2025/26 flu season has been cancelled.

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Vaccines FDA 110

Pharmaceutical Technology

JANUARY 15, 2025

Incyte told JP Morgan attendees of plans for four launches in 2025, beginning with its FDA-approved Niktimvo for chronic GvHD.

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FDA 59

Fierce Pharma

AUGUST 19, 2024

Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod. | The agency granted a broad regulatory exclusivity to rival United Therapeutics and its Tyvasvo DPI, leaving Liquidia's Yutrepia, which uses the same active drug, in FDA limbo until 2025.

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FDA 78

Fierce Pharma

OCTOBER 24, 2023

The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent. The company expects a decision in the first quarter of next year and is making plans to launch the treatment in the 2024-2025 flu season.

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Vaccines FDA 93

Pharmaceutical Technology

FEBRUARY 18, 2025

The FDA has accepted Gileads new drug application with a decision expected by 19 June 2025.

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FDA 71