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

OCTOBER 10, 2022

Immutep claimed fast-track status from the FDA for efti last week as a combination therapy alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) for previously-untreated non-small cell lung cancer (NSCLC), based on the results of the phase 2 TACTI-002 study. month mPFS with Keytruda plus chemo, with fewer side effects.

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Chemotherapy FDA 59

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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Chemotherapy Immunization FDA Vaccines 99

pharmaphorum

OCTOBER 4, 2020

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

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Immunization Chemotherapy FDA 97

pharmaphorum

DECEMBER 5, 2022

The trial tested Jemperli given alongside chemotherapy with carboplatin and paclitaxel, followed by Jemperli alone, to a control group given placebo plus chemo followed by placebo.

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Chemotherapy Labelling FDA 52

PharmaShots

MARCH 29, 2023

Lupin has earned the US FDA approval for the generic version of Banzel as Rufinamide Oral Suspension. It is the only drug in its class of chemotherapy and is developed from the natural substance found in a sea sponge. The exact mechanism of action is uncertain. Glenmark has also released its generic drug version in the US market.

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FDA Chemotherapy Immunization Dosage 49

Hospital Pharmacy Europe

FEBRUARY 15, 2024

They are] administered by the same nurses who would normally give chemotherapy’, Dr Tucker says. The FDA is already talking up what it calls ‘a dizzying array’ of potential formats for multispecific antibodies, which can target multiple antigens simultaneously and, it says, ‘may lead to treatments for diseases with no or few therapies’.

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Chemotherapy Hospitals Immunization Vaccines 52

The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.

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FDA Controlled Substances Chemotherapy Compounding 69

European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb]. cited 2024Feb].

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Immunization Chemotherapy FDA Pharmaceutical Companies 85

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Dosage FDA Pharmaceutical Companies Pharmaceutical Companies 115

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024.

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FDA Vaccines Chemotherapy Communication 98

STAT

JULY 31, 2023

… House Republicans have drafted drug-shortage legislation that differs significantly from the approach Democrats propose to stem shortages of chemotherapies and other critical medicines that hospitals typically use , STAT explains. Republicans We value your postcards and telegrams.

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FDA Chemotherapy Hospitals 75

Pharmaceutical Technology

MARCH 29, 2023

In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. Stéphane Thiroloix, CEO of AlgoTx Alongside erythromelalgia, the company is testing ATX01 in a Phase II study in chemotherapy-induced peripheral neuropathy (CIPN). The company expects to have data from both trials ready in mid-2024, says Thiroloix.

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Chemotherapy Compounding Communication FDA 52

The FDA Law Blog

FEBRUARY 11, 2024

FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024).

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Controlled Substances Chemotherapy Compounding FDA 59

The FDA Law Blog

MAY 5, 2024

Last August, the Food and Drug Administration (“FDA”) and HHS, after considering the eight-factor analysis required by the Controlled Substances Act (“CSA”) for scheduling substances of abuse, recommended DEA reschedule marijuana from schedule I to schedule III. 29, 2023). Letter to DEA Administrator Anne Milgram, from Phil Weaver, et al.

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Controlled Substances FDA Chemotherapy Dosage 91