MedCity News

OCTOBER 24, 2024

This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. The post 4 Things That Worry FDA Commissioner Robert Califf appeared first on MedCity News.

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European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.

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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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European Pharmaceutical Review

JULY 7, 2025

The US Food and Drug Administration (FDA) has approved the first oral on-demand therapy for acute attacks of hereditary angioedema (HAE) in individuals aged 12 years and older. The post FDA approves first-of-a-kind oral therapy for rare disease appeared first on European Pharmaceutical Review.

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MedCity News

MARCH 16, 2023

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration. Insurers need to help, he said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum.

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Fierce Pharma

JANUARY 22, 2024

Food and Drug Administration’s crosshairs, Reuters first reported. Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S.

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European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

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PharmaVoice

FEBRUARY 9, 2023

FDA’s food program is in for a major overhaul — here’s why pharma should pay attention.

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Fierce Pharma

JULY 26, 2023

Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again. |

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Pharmaceutical Technology

FEBRUARY 20, 2024

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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Pharmaceutical Technology

MAY 21, 2025

The US Food and Drug Administration (FDA) is set to restrict the Covid-19 booster doses to older adults and those at risk of severe illness.

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Pharmaceutical Technology

MAY 15, 2025

Kaerus Bioscience has received US Food and Drug Administrations (FDA) designations for KER-0193 to treat Fragile X syndrome (FXS).

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Pharmaceutical Technology

MAY 15, 2025

The US Food and Drug Administration (FDA) has accepted BioCryst Pharmaceuticals new drug application (NDA) for Orladeyo.

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? Higher numeracy was associated with better gist and verbatim recall.” ” Uh…no.

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

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Pharmaceutical Technology

MAY 29, 2025

Eton Pharmaceuticals NDA for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval.

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World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. Food and Drug Administration on Biogen Inc.’s ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast. .’s

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PharmaVoice

JANUARY 23, 2024

What started as an examination of the Human Foods Program has expanded into an agency-wide overhaul.

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pharmaphorum

OCTOBER 4, 2024

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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Pharmaceutical Technology

AUGUST 8, 2024

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

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World of DTC Marketing

JULY 15, 2021

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. According to STAT News, “acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.”

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Pharmaceutical Technology

MAY 23, 2025

GSK has received approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab).

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Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training.

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Nixon Gwilt Law

MARCH 6, 2025

On February 21, 2025 , the FDA officially determined that the shortage of semaglutide injection products has been resolved. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.

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Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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Pharmaceutical Technology

SEPTEMBER 13, 2024

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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pharmaphorum

JANUARY 16, 2025

The FDA has banned the use of a red dye used in oral medicines, foods, and dietary supplements, more than 30 years after it was linked to cancer.

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Pharmaceutical Technology

NOVEMBER 14, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

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Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

JUNE 3, 2024

Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).

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PharmaTimes

NOVEMBER 23, 2023

ADP101 is an oral immunotherapy to treat multi-food and single-food allergies - News - PharmaTimes

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European Pharmaceutical Review

MAY 2, 2025

The US Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) as the first autologous cell-based gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds. Also known as pz-cel, the cell sheet-based treatment is applied via a single surgical application.

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Pharmaceutical Technology

DECEMBER 4, 2023

The US Food and Drug Administration (FDA) has granted approval for Ambio’s generic version of Forteo for the treatment of osteoporosis.

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