STAT

AUGUST 9, 2024

Although two Phase 3 trials suggested the treatment was effective, strong opposition by an agency scientific advisory committee in June and allegations of missing adverse event data and research bias may have doomed the application by Lykos Therapeutics. Read the rest…

FDA 145

FDA 145

Pharmacy Times

NOVEMBER 14, 2024

The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.

Labelling 139

Labelling FDA 139

Fierce Pharma

DECEMBER 9, 2023

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. |

FDA 101

FDA 101

The Checkup by Singlecare

JANUARY 9, 2025

Ozempic and Wegovy are also used to reduce the risk of major cardiovascular events. Food and Drug Administration (FDA). Their purpose is to meet an individual patients specific needs when an FDA-approved drug doesnt. The FDA has a drug shortage list, and injectable semaglutide is currently in low supply.

Compounding 104

Compounding Compounding Pharmacies FDA Sterile Compounds 104

STAT

SEPTEMBER 11, 2024

— At an event with journalists Tuesday outside of Boston, U.S. This summer, the FDA expanded Sarepta Therapeutics’ accelerated approval for the Duchenne muscular dystrophy gene therapy Elevidys , despite the drug failing its Phase 3 trial. Some decried the decision, including former FDA chief scientist Luciana Borio.

FDA 141

FDA 141

STAT

OCTOBER 25, 2024

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans.

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FDA Compounding Pharmacies Compounding 142

The FDA Law Blog

JANUARY 29, 2025

With oversight over FDA, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention, Kennedys portfolio will be vast. We dont know if the hearings will get even ankle deep into the actual management of FDA. Kennedy, Jr.

FDA 59

FDA Vaccines 59

The Checkup by Singlecare

JANUARY 31, 2025

Food and Drug Administration (FDA) expanded Ozempics indication to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). Other approved uses of semaglutide This is not the first time that the FDA has expanded the use of semaglutide.

FDA 66

FDA 66

Fierce Pharma

AUGUST 16, 2024

A large number of missing adverse events in South Korea triggered a full-scale check-up during the FDA's review of Amgen's Imdelltra. . | Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. And more.

FDA 80

FDA 80

Pharmacy Times

APRIL 5, 2024

These FDA-approved therapies are used to treat lymphoma after 2 or more lines of therapy and represent significant advancements in the treatment of lymphoma.

FDA 122

FDA 122

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.

FDA 59

FDA 59

Pharmaceutical Technology

NOVEMBER 12, 2024

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

Vaccines 104

Vaccines FDA 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 Communication Labelling Insurance 138

STAT

JANUARY 4, 2023

Heavyweight investors, analysts and entrepreneurs will descend upon San Francisco the following week, with keynotes from JPMorgan Chase head Jamie Dimon and FDA Commissioner Robert Califf.  Coming up first is consumer tech expo CES, which begins later this week in Las Vegas, and promises to reveal dozens of new wearables.

FDA 143

FDA 143

STAT

OCTOBER 25, 2024

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans.

FDA 113

FDA Compounding Pharmacies Compounding 113

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.

FDA 105

FDA 105

PharmExec

NOVEMBER 30, 2023

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially fatal reaction linked to use of antiseizure medications.

FDA 98

FDA 98

The Checkup by Singlecare

DECEMBER 23, 2024

Food and Drug Administration (FDA) to help control blood sugar in patients with Type 2 diabetes. Another exciting effect of GLP-1s is their potential to reduce the risk of major adverse cardiovascular events like heart attack and stroke. Keep reading to learn how semaglutide and other GLP-1s improve cardiovascular risk factors.

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FDA Labelling Hospitals 98

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

FDA 105

FDA Insurance Coverage Insurance 105

pharmaphorum

APRIL 19, 2022

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. The post GSK goes for gold as FDA starts review of daprodustat appeared first on.

FDA 122

FDA 122

European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

Hospitals 105

Hospitals FDA Medical Schools 105

Pharmacy Times

MARCH 4, 2025

The FDA is issuing new changes to labels on testosterone products, clarifying that there are no increases in major cardiac events among men with hypogonadism but noting an increase in blood pressure with the use of such products.

Labelling 89

Labelling FDA 89

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. FDA’s sampling and testing programme found 892 of 1,552 product samples (57.5

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FDA Labelling 105

STAT

AUGUST 12, 2024

Although two Phase 3 trials suggested the treatment was effective, strong opposition by an agency scientific advisory committee in June and allegations of missing adverse event data and research bias may have doomed the application from Lykos Therapeutics.

FDA 114

FDA 114

The Checkup by Singlecare

JANUARY 19, 2024

Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier?

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FDA Dosage Insurance 105

STAT

JUNE 5, 2023

On Sunday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, took issue with his boss. It’s true that the FDA has no obligation to follow what the advisory committee recommends, but the votes help, Pazdur said at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting.

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FDA 97

European Pharmaceutical Review

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche’s CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

FDA 105

FDA 105

The Checkup by Singlecare

MARCH 13, 2024

Food & Drug Administration (FDA) approved Jubbonti and Wyost, the first interchangeable biosimilars to the injectable medications Prolia and Xgeva , respectively. For traditional medications, the FDA can approve generic medications. In other words, biosimilars go through the same FDA approval process as all other medications.

FDA 98

FDA Dosage Insurance 98

European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Clinical study of Adstiladrin.

FDA 110

FDA Adverse Reactions Immunization Vaccines 110

Pharmacy Times

NOVEMBER 10, 2023

The on-demand enzyme replacement therapy reduced acute thrombotic thrombocytopenic purpura events in patients who experience potentially fatal blood clotting.

FDA 123

FDA 123

The FDA Law Blog

MARCH 12, 2025

PTOs PTAB, the FTC, and the FDA, to tackle the critical legal, regulatory, and business issues shaping pharmaceutical patent litigation. FDA Law Blog is a conference media partner. You can access the conference brochure and sign up for the event here. As such, we can offer our readers a special 10% discount.

FDA 59

FDA 59

STAT

SEPTEMBER 28, 2023

The FDA received more than 250 reports of patients experiencing suicidal thoughts or behaviors while taking Ozempic or similar medicines since 2010 , Reuters reports, citing an examination of the FDA adverse-event database. Thirty-six of these reports describe a death by suicide or suspected suicide.

FDA 116

FDA 116

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP).

FDA 97

FDA 97

pharmaphorum

JANUARY 9, 2023

We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf.

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FDA 119

The Checkup by Singlecare

MARCH 10, 2025

Some are also approved to help lower the risk of heart disease and cardiovascular events in people with diabetes or obesity. It is the active ingredient in the brand-name , FDA-approved drugs Ozempic , Wegovy , and Rybelsus. Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide.

Compounding 80

Compounding Dosage FDA Labelling 80

Pharmacy Times

MARCH 4, 2025

The new approval expands the portfolio of denosumab biosimilars, increasing access and improving costs for patients.

FDA 73

FDA 73

The Checkup by Singlecare

JANUARY 16, 2025

Some options include : Repatha (evolocumab) is a brand-name medication that is FDA approved to lower cholesterol and reduce the risk of heart attacks and strokes, by helping to restore blood flow to the heart in individuals with heart disease. It first gained FDA approval in 2015.

Dosage 98

Dosage FDA Compounding Hospitals 98