pharmaphorum

FEBRUARY 15, 2021

To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data that made it a rising star at that year’s American Society of Clinical Oncology (ASCO) conference. months in the chemotherapy group. of patients in the chemotherapy arm.

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Chemotherapy FDA 69

pharmaphorum

JUNE 11, 2021

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences.

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Chemotherapy Labelling FDA 83

Pharmaceutical Technology

JUNE 4, 2023

Patients with resectable stage II, IIIA, and IIIB (T3-4N2) disease of both squamous and non-squamous histology were randomized to receive neoadjuvant Keytruda with platinum-based chemotherapy followed by adjuvant Keytruda, or placebo with platinum-based chemotherapy followed by placebo. At a median duration of follow-up of 25.2

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Chemotherapy Hospitals FDA 75

pharmaphorum

DECEMBER 13, 2021

In ZUMA-7, second-line treatment of relapsed or refractory LBCL patients with Yescarta extended median event-free survival (EFS) to 8.3 Gilead has already filed for approval to extend the label for Yescarta to include second-line LBCL in the US and Europe, and is anticipating an FDA decision by 1 April next year.

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Chemotherapy Labelling FDA 98

Pharmaceutical Technology

MARCH 6, 2023

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

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Chemotherapy FDA Labelling Immunization 52

Pharmaceutical Technology

APRIL 4, 2023

The ORR and OS metrics surpassed the standard of care of gemcitabine plus nab-paclitaxel, and indicated potential complementary activity with the current standard chemotherapy regimen approved by the FDA.

Chemotherapy 59

Chemotherapy Compounding FDA 59

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

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FDA Communication Chemotherapy Labelling 52

pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 The post FDA slaps hold on trials of Gilead’s CD47 drug magrolimab appeared first on. billion acquisition of Forty Seven in 2020.

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FDA Adverse Reactions Chemotherapy Immunization 40

European Pharmaceutical Review

DECEMBER 28, 2023

As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.

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Immunization Chemotherapy Medical Schools FDA 84

pharmaphorum

JUNE 12, 2022

The new data comes just after bluebird bio’s gene therapy for TDT – betibeglogene autotemcel (beti-cel) – was recommended for approval by an FDA advisory committee on Friday, setting it up to possibly reach the US market later this year. There have also ben no cases of cancer – a concern with bluebird’s gene therapy approach.

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Chemotherapy FDA 59

pharmaphorum

NOVEMBER 29, 2022

Those immunologically cold gastrointestinal tumours present a real clinical challenge, with a standard of care heavily relying on chemotherapy approaches. No serious adverse events were observed. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options.

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Immunization Chemotherapy Compounding FDA 105

Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

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Chemotherapy Labelling FDA Communication 52

The Checkup by Singlecare

NOVEMBER 21, 2024

Botanical drugs According to the Michigan State University Center for Research on Ingredient Safety, botanical drugs are regulated by the FDA in the same way as prescription and over-the-counter drugs. This means the FDA reviews botanical medications for safety and efficacy before being approved. Its drug interaction risk is low.

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FDA Labelling Chemotherapy Dosage 52

The Checkup by Singlecare

OCTOBER 16, 2023

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. Cymbalta may have several off-label uses in addition to its FDA-approved uses. It is also approved for fibromyalgia and chronic muscle pain. Approved by the U.S.

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Dosage Insurance Coverage Labelling Insurance 52

Pharmacy Times

JUNE 13, 2025

Vitamin D supplementation increased 25-hydroxyvitamin-D levels significantly, suggesting a potential role in enhancing chemotherapy effectiveness. The study's findings support further research with larger samples to explore vitamin D's impact on chemotherapy and breast cancer remission likelihood.

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Chemotherapy Immunization Compounding Pharmacies Hospitals 141

The Checkup by Singlecare

MARCH 23, 2023

By inhibiting CYP3A4, CBD/THC can increase patients’ exposure to these medications, increasing the risk of toxicity and adverse events. The Food and Drug Administration (FDA) approved the drug to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.

Controlled Substances 52

Controlled Substances Medical Records Chemotherapy Compounding 52

Pharmacy Times

JUNE 25, 2025

Safety profiles were manageable, with similar rates of grade 3 or higher adverse events between the treatment groups. months versus 7.79 months with tislelizumab. months versus 7.79 months with tislelizumab. The overall response rate was higher in the benmelstobart group at 71.9% compared to 65.1% in the tislelizumab group.

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Chemotherapy Compounding Pharmacies Immunization Compounding 50

PharmaShots

FEBRUARY 13, 2023

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. The most common treatment-related adverse events (AEs) included edema, thrombocytopenia, anemia and nausea. Across both presentations, safety results were consistent with previously reported data.

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Chemotherapy Immunization FDA 40

PharmaShots

FEBRUARY 13, 2023

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. The most common treatment-related adverse events (AEs) included edema, thrombocytopenia, anemia and nausea. Across both presentations, safety results were consistent with previously reported data.

Chemotherapy 40

Chemotherapy Immunization FDA 40

Pharmacy Times

JUNE 11, 2025

The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.

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FDA Compounding Pharmacies Immunization Hospitals 73

Pharmacy Times

JUNE 19, 2025

1 Biomarker testing is relatively new in the treatment landscape for NSCLC but has proven incredibly important for personalizing patient care, transforming from a generic chemotherapy approach to a highly personalized, genomically driven treatment strategy. For advanced disease, chemotherapy was the standard.

Chemotherapy 73

Chemotherapy Compounding Pharmacies Hospitals Immunization 73

Pharmacy Times

JUNE 23, 2025

The FDA's decision represents progress in treating EGFR-mutated NSCLC beyond initial therapy lines. SHOW MORE Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.

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FDA Compounding Pharmacies Chemotherapy Immunization 86

Pharmacy Times

JUNE 10, 2025

Meloxicam injection (Xifyrm; Azurity Pharmaceuticals, Inc) received FDA approval for use in adults for the management of moderate-to-severe pain, either alone or in combination with non-steroidal anti-inflammatory drug (NSAID) analgesics. The approval offers patients a new intravenous (IV) formulation of meloxicam.

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FDA HIV Treatment and Prevention Agents Compounding Pharmacies Hospitals 73

The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. Tegaserod : This medication was approved for IBS-C in 2002, but removed from the market in 2007 due to an increased risk of cardiovascular events.

Health and Personal Care Stores 84

Health and Personal Care Stores Chemotherapy Immunization Compounding 84

Pharmaceutical Technology

JULY 3, 2025

Dizal has received US Food and Drug Administration (FDA) approval for Zegfrovy (sunvozertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), following progression on or after receiving platinum-based chemotherapy.

FDA 52

FDA Packaging Communication Hospitals 52

Pharmacy Times

JUNE 16, 2025

Transportation barriers, as a health-related social need, significantly impact FN rates in chemotherapy patients. Febrile neutropenia (FN) remains a serious and common complication of chemotherapy. A 67% FN rate difference between pegfilgrastim and filgrastim was observed in patients with transportation barriers.

HIV Treatment and Prevention Agents 73

HIV Treatment and Prevention Agents Chemotherapy Compounding Pharmacies Immunization 73

Pharmaceutical Technology

JULY 1, 2025

The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. Credit: HenadziPechan/Shutterstock. Sign up for our daily news round-up!

FDA 52

FDA Packaging Communication Hospitals 52

Pharmacy Times

JUNE 18, 2025

Mok : Right now, we have a lot of chemotherapy being used, but there are many more novel treatments being studied, especially in earlier lines of treatment. Bispecifics are moving up in the lymphoma space, and these newer therapies may have some synergistic effects with chemotherapy. REFERENCES 1. Updated August 18, 2021.

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Chemotherapy Compounding Pharmacies Immunization Hospitals 65

Pharmacy Times

JUNE 20, 2025

News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)

Compounding 107

Compounding Compounding Pharmacies Patient Care Immunization 107

Pharmacy Times

JUNE 9, 2025

Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. N Engl J Med. 2019;380:2020-2030. Subscribe Now!

Compounding Pharmacies 73

Compounding Pharmacies Hospitals Immunization Chemotherapy 73

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The median OS in patients on quizartinib was 31.9

FDA 98

FDA Chemotherapy 98

Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

FDA 65

FDA Compounding Pharmacies Dosage Hospitals 65

Pharmacy Times

JUNE 11, 2025

Approximately 40% to 80% of patients with cancer who are assigned female at birth face possible infertility as a result of their cancer treatments, such as chemotherapy, radiation, and surgery. An additional 15% to 30% of cancer survivors who are assigned male at birth also face infertility as a result of chemotherapy.

Specialty Pharmacies 73

Specialty Pharmacies Compounding Pharmacies Immunization Chemotherapy 73

Pharmaceutical Technology

JULY 4, 2025

Go deeper with GlobalData Reports LOA and PTSR Model - Denosumab Biosimilar in Bone Metastasis Reports LOA and PTSR Model - Denosumab Biosimilar in Chemotherapy Effects Data Insights The gold standard of business intelligence. By inhibiting RANKL, denosumab hampers the bone degradation process, bolstering bone density and strength.

Chemotherapy 52

Chemotherapy Packaging Communication Hospitals 52

Pharmacy Times

JUNE 17, 2025

Of these patients, 59 (50%) experienced a total of 112 all-cause dosage modification events during the first year of use: dose reductions (30/112, 26%), dosage interruptions (51/112, 46%), dose discontinuations (28/112, 25%), and others (3/112, 3%). Fifty-two percent (58/112) of dose modification events occurred in the first 6 months.

Dosage 65

Dosage Compounding Pharmacies Immunization Chemotherapy 65

Pharmacy Times

JUNE 9, 2025

Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. Subscribe Now!

Compounding Pharmacies 73

Compounding Pharmacies Hospitals Immunization Chemotherapy 73

Pharmacy Times

JUNE 17, 2025

Among the 37 practices that reported waste, 768 events were reported, leading to a total drug waste of $11,275,642.16. These events foster innovation, collaboration, and professional growth within the oncology pharmacy community. compared with $546,082.45 for the external mail-order pharmacies. Of that, $8,935,612.15

Mail-Order Pharmacies 73

Mail-Order Pharmacies Compounding Pharmacies Medical Records Dosage 73