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 122

Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The FDA has already endorsed it for people 60 and older. The results could pave the way for the shot to be approved for this age group.

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Labelling Vaccines FDA 109

pharmaphorum

MAY 20, 2024

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th July @ 07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST.

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Labelling FDA 119

pharmaphorum

JUNE 20, 2024

Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.

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Labelling FDA 111

Fierce Pharma

DECEMBER 16, 2024

The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD). | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

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Labelling FDA 76

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

Fierce Pharma

DECEMBER 5, 2024

AstraZeneca has picked off another label expansion for cancer blockbuster Imfinzi as the FDA has blessed it for limited-stage small cell lung cancer.

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FDA Labelling 122

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

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

Drug Topics

JUNE 29, 2023

The approval was based on safety and efficacy data from 30 participants in 2 open-label, single-arm studies that received 1 to 3 infusions of donislecel.

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Labelling FDA 187

Fierce Pharma

MAY 30, 2024

In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. | In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy.

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FDA Labelling 129

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

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

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

SEPTEMBER 26, 2024

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.

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FDA Labelling 122

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

Fierce Pharma

OCTOBER 25, 2024

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. The FDA nod marks the second approval this year for a uUTI medicine after two decades of stagnation in the field.

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FDA Labelling 123

The Checkup by Singlecare

DECEMBER 19, 2024

Food and Drug Administration (FDA) is sounding the alarm about the risks of using unapproved GLP-1s. Earlier this month, the FDA posted four warning letters to companies that have introduced unapproved GLP-1s, such as semaglutide, tirzepatide, and retatrutide, into interstate commerce. But the U.S. Which companies are affected?

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Compounding FDA Labelling Compounding Pharmacies 81

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

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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FDA Labelling 115

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.

FDA 141

FDA Labelling Immunization 141

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 140

Fierce Pharma

JUNE 16, 2023

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma.

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FDA Labelling 131

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

APRIL 26, 2024

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

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Labelling FDA 123

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

Fierce Pharma

SEPTEMBER 24, 2024

and BeiGene.

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FDA Labelling 104

STAT

AUGUST 20, 2024

And a group of researchers — including two from the FDA’s Center for Drug Evaluation and Research — think artificial intelligence could uncover more signs of these issues, including from electronic health records, social media posts, and clinical databases referencing certain drugs.  

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FDA Labelling Communication Insurance 138

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. Clinical trials of the FDA approved Rykindo ®. The post FDA approves long-acting injectable for schizophrenia and bipolar disorder appeared first on European Pharmaceutical Review.

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FDA Labelling 122

Pharmacy Times

APRIL 29, 2024

The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.

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Labelling FDA 145

Pharmaceutical Technology

MAY 15, 2024

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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Vaccines Labelling FDA 98

pharmaphorum

OCTOBER 23, 2024

A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference in the battle for market share.The US regulator has cleared Abrysvo for use in adults aged 18 to 59 at risk of RSV-related disease, extending its earlier label (..)

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FDA Labelling Vaccines 103

IDStewardship

OCTOBER 27, 2022

” New antibiotics coming to the market must have a reasonable degree of safety and efficacy to achieve FDA-approval. Myth 9: Penicillin allergy labels are not a big deal. Approximately 10% of the US adult population has a penicillin allergy label and only about 10% of those labels represent true allergies.

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Labelling FDA 364

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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FDA Labelling Dosage 104

Fierce Pharma

DECEMBER 18, 2024

Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling.

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Labelling FDA 60

Pharmafile

APRIL 14, 2023

Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine.

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FDA Packaging Labelling Immunization 119

Fierce Pharma

DECEMBER 20, 2023

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has

Labelling 124

Labelling FDA 124