PharmExec

MARCH 28, 2025

Based on additional results from the Phase III PSMAfore clinical trial, the therapy is now approved for use prior to chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer.

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pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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The Checkup by Singlecare

JUNE 17, 2024

When over-the-counter (OTC) remedies don’t cut it, your healthcare provider may prescribe Zofran ( ondansetron ), a medication used to treat upset stomach and prevent vomiting—especially when caused by chemotherapy, radiation therapy, and surgery. It’s also can be used off-label to treat morning sickness during pregnancy.

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pharmaphorum

APRIL 29, 2021

That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional approvals in six cancers that subsequently failed studies designed to confirm their benefits.

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pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. It can be used in in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Servier is on course to get a return on its $1.8 for the control group.

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FDA Chemotherapy Labelling 52

pharmaphorum

SEPTEMBER 26, 2022

The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.

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The Checkup by Singlecare

NOVEMBER 21, 2024

Adults and children weighing more than 40 kg (88 lbs) Adults, children, and infants 1 month and older Conditions treated by famotidine and pantoprazole Famotidine is FDA-approved to treat stomach ulcers and duodenal ulcers, while pantoprazole is often prescribed off-label for both ulcerative conditions. pylori) in the stomach.

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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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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.

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pharmaphorum

DECEMBER 13, 2021

“The current standard of care consisting of chemotherapy and transplant is not effective at curing most patients with high risk relapsed large B-cell lymphoma, representing a huge unmet need in our field,” commented Manali Kamdar of the University of Colorado Cancer Centre, a TRANSFORM investigator.

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pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 The FDA has granted an accelerated approval based on data from the ongoing phase 1 GARNET trial, meaning that GSK will have to produce survival data for the drug to remain on the market in the long term.

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pharmaphorum

MARCH 8, 2021

AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.

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pharmaphorum

AUGUST 4, 2022

The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-hormonal therapy.

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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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pharmaphorum

AUGUST 31, 2022

The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

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pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year.

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European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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pharmaphorum

APRIL 30, 2021

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients. .

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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

DECEMBER 5, 2022

Pluvicto becomes the first PSMA-targeted intravenous radioligand therapy – combining a targeting compound or ligand with a therapeutic radionuclide or radioactive particle (in this case, lutetium-177) – to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy.

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pharmaphorum

AUGUST 9, 2022

The data provide proof-of-principle for the use of MET-targeting drugs to offset Tagrisso resistance, and charts a way forward towards regulatory approvals of the combination as an alternative to chemotherapy for these patients. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. ORR, 81.0% DCR (disease control rate), 4.37

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pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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pharmaphorum

JULY 22, 2021

After initially turning down Pemazyre in draft guidance published in May, NICE has now backed routine NHS use of the drug as a second-line therapy for advanced cholangiocarcinoma patients – previously treated with chemotherapy – whose tumours have a fibroblast growth factor receptor2 (FGFR2) fusion or rearrangement.

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pharmaphorum

FEBRUARY 7, 2022

The drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for this type of cancer in June 2021 based on results from the GARNET trial , which included women who progressed on or after platinum-based chemotherapy.

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pharmaphorum

JANUARY 11, 2022

The top-line result means Merck can now plan marketing applications to extend the label of Keytruda into the adjuvant setting in NSCLC, in the hope of catching up with Tecentriq (atezolizumab), which was approved by the FDA in this setting last October.

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Labelling Chemotherapy FDA 59

pharmaphorum

MAY 31, 2021

The FDA has also approved companion diagnostics from Guardant Health and Qiagen to identify patients eligible for treatment with the new drug. KRAS mutations are seen in around a quarter of NSCLC tumours, with KRAS G12C mutations in particular found in around 13% of cases. It is estimated there are around 25,000 new cases per year in the US.

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The Checkup by Singlecare

APRIL 16, 2023

| How to get ondansetron without insurance Ondansetron hydrochloride is a generic prescription drug that is FDA -approved to relieve nausea and vomiting in people undergoing cancer chemotherapy or radiation therapy. Additionally, it is sometimes prescribed off-label to treat morning sickness during pregnancy.

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The Checkup by Singlecare

OCTOBER 8, 2024

Ozempic (semaglutide) is a weekly prescription medication that is approved by the Food and Drug Administration (FDA) to help control blood glucose levels in people with Type 2 diabetes. It is also sometimes prescribed off-label (for a non-FDA-approved use) for weight loss.

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Immunization Chemotherapy FDA Labelling 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. What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Approved by the U.S.

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Hospital Pharmacy Europe

NOVEMBER 6, 2023

Adagrasib is a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

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Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status.

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pharmaphorum

DECEMBER 5, 2022

The positive news comes after a challenging time for GSK, marked by the withdrawal of its US marketing approval for multiple myeloma therapy Blenrep (belantamab mafodotin) last month, along with the narrowing of the label for PARP inhibitor Zejula (niraparib), as well as a retreat from the cell therapy category.

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The Checkup by Singlecare

DECEMBER 13, 2023

Antiemetics may also reduce radiation-associated or chemotherapy-induced nausea resulting from cancer treatment. Be sure to follow the dosing instructions on the label for your child’s age. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting.

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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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