STAT

JUNE 20, 2023

WASHINGTON — The FDA wants to make it easier for consumers to know if the foods they’re buying are unhealthy — but doing so is harder than it seems here in the United States. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,

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Packaging Labelling Grocery Stores FDA 98

pharmaphorum

NOVEMBER 17, 2023

AZ first to AKT finish line, but FDA clears narrow label Phil.Taylor Fri, 17/11/2023 - 09:46 Bookmark this

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Labelling FDA 105

pharmaphorum

MARCH 11, 2024

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese

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Labelling FDA 111

STAT

DECEMBER 22, 2023

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy. 

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Labelling Chemotherapy FDA Patient Care 115

Pharmaceutical Technology

APRIL 24, 2024

Lutathera is approved by the US FDA to treat patients aged 12 years and older with rare gastroenteropancreatic neuroendocrine cancer.

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Labelling FDA 52

Pharmacy Times

DECEMBER 5, 2023

The approval marks levothyroxine sodium as the only FDA-granted LT4 therapy that does not have a labeled interaction with PPIs and can be taken 15 minutes prior to eating breakfast.

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Labelling FDA 65

Fierce Pharma

DECEMBER 19, 2022

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. Mon, 12/19/2022 - 11:13.

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Labelling FDA 115

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Labelling FDA Vaccines Communication 40

STAT

MARCH 28, 2024

WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can?

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FDA Labelling 124

Pharmacy Times

MARCH 22, 2024

Bempedoic acid (Nexletol; Esperion) and bempedoic acid and ezetimibe (Nexlizet; Esperion) are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

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Labelling FDA 152

Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Documentation FDA 52

BioPharm

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Documentation FDA 52

The FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. GSK skinny label case , the U.S. The Government’s concern goes far beyond this case: Like many generic drug sponsors, the Government raises concerns of the implications of the outcome of this case on the skinny label pathway itself.

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Labelling FDA Documentation Communication 72

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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Documentation Labelling FDA Packaging 59

The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved.

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Labelling FDA Documentation 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Labelling FDA 52

Fierce Pharma

APRIL 18, 2024

Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval< | AbbVie's Rinvoq has racked up seven FDA approvals in recent years, and another expansion into giant cell arteritis could be in the cards after a positive trial.

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Labelling FDA 105

Pharmacy Times

DECEMBER 14, 2023

The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.

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Labelling FDA 139

The FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Fierce Healthcare

DECEMBER 11, 2023

Floreo, maker of virtaul reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. | Floreo says it seeks full market authorization to further recognize its effectiveness and to open up reimbursement pathways for its tech to reach more families.

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Labelling FDA 128

Fierce Pharma

NOVEMBER 17, 2023

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

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FDA Labelling 129

Fierce Pharma

OCTOBER 27, 2023

After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population.

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Labelling FDA 103

The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Labelling FDA 45

The FDA Law Blog

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

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Labelling FDA 59

The FDA Law Blog

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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Labelling FDA Packaging 40

Fierce Pharma

JANUARY 24, 2024

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday.

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Fierce Pharma

JANUARY 22, 2024

When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand. When the FDA converts an accelerated approval into a full nod, it's typically associated with a wider label for the drug at hand.

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FDA Labelling 110

Pharmacy Times

JANUARY 16, 2023

Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.

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Labelling FDA 123

BuzzRx

JANUARY 27, 2023

Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. The term “on-label use” of a drug may seem unfamiliar to most people.

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Labelling FDA Dosage Pharmaceutical Companies 52

Fierce Pharma

APRIL 16, 2024

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

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Labelling FDA 128

Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

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Adverse Reactions FDA Labelling 134

STAT

NOVEMBER 7, 2023

1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts , who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken. Read the rest…

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FDA Labelling 145

Drug Topics

MARCH 22, 2024

The approval represents the first non-statin treatment indicated to lower low-density lipoprotein for primary prevention patients.

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Labelling FDA 98

STAT

NOVEMBER 28, 2023

Now, for the first time, a nonprofit group is pursuing research with the goal of FDA approval for the use of estrogen as a gender-affirming treatment for trans and gender-diverse patients. 17 in lieu of a live pre-investigational new drug meeting. Read the rest…

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FDA Labelling 136

Fierce Pharma

JANUARY 4, 2024

Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products.

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FDA Labelling 137

Fierce Pharma

OCTOBER 16, 2023

Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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Fierce Pharma

APRIL 18, 2024

Two weeks after gaining a hard-earned FDA label expansion for its long-established antipsychotic drug Fanapt (iloperidone), Vanda Pharmaceuticals has derailed a hostile takeover bid. |

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Labelling FDA 105