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. |

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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.

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Compounding Compounding Pharmacies FDA Sterile Compounds 104

STAT

SEPTEMBER 17, 2024

Called “AI in Action: Transforming Health and Human Services,” the three-hour event is hosted by the federal health department. Federal health officials wrestling with when and how to use artificial intelligence will on Wednesday host an invitation-only meeting of AI leaders across industry, academia, and government.

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Medical Schools FDA Hospitals 108

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.

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FDA 131

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 132

Hospital Pharmacy Europe

MARCH 15, 2023

But despite the value of these drugs, in the US, the FDA issued warnings about the risk of neuropsychiatric side effects (NSE)-related to the use of one leukotriene antagonist, montelukast and which often occurred within the first 10 days of use and were most common in 4 – 6 year old children. Citation Tsai HJ et al.

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Hospitals FDA 98

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.

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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.

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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.

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FDA 59

ISPE

NOVEMBER 23, 2022

ISPE Represented at PIC/S 50th Anniversary Event. ISPE Represented at PIC/S 50th Anniversary Event. The PIC/S Deputy Chairperson, Susan Laska, US FDA, outlined the evolution of pharma industry and PIC/S, including background information on the operations of PIC/S. Trudy Patterson. Wed, 11/23/2022 - 06:50. iSpeak Blog.

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Documentation FDA Communication 98

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.

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Vaccines FDA 104

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.

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FDA 135

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 123

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 103

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.

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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.

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FDA 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).

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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.

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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).

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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.

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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

pharmaphorum

DECEMBER 15, 2021

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The post FDA sets April date for verdict on Incyte’s vitiligo drug appeared first on. 52-week data is expected in the coming weeks.

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FDA 111

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

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. Overall survival was the trial’s primary endpoint.

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FDA Chemotherapy 98

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.

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FDA Dosage Insurance 98

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.

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FDA 105

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.

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FDA 123

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.

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FDA 105

European Pharmaceutical Review

DECEMBER 2, 2022

has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Rigel Pharmaceuticals, Inc. Clinical safety data of Rezlidhia for AML.

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FDA Labelling 98

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A milestone for retinal ophthalmology The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade.”

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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).

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FDA 97

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 92

Pharmaceutical Technology

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology.

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FDA 98

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

Pharmacy Times

MARCH 4, 2025

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

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FDA 73

The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. This approval is noteworthy because in 2022 the FDA found nitrosamine impurities in certain samples of sitagliptin , raising concerns about potential shortages of these two drugs. What are the possible side effects of Zituvio?

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FDA Dosage 98