Clarivate

JUNE 26, 2023

Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. These differentiators can inform commercial strategies.

Food and Drug Administration 52

Food and Drug Administration Patients Side effects Medicine 52

European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

Patients 52

Patients Food and Drug Administration Side effects Food 52

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. 2022; 7(93) Maecker et al.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

pharmaphorum

OCTOBER 13, 2022

In October 2022, the companies announced their plan to file exagamglogene autotemcel, the CRISPR/Cas9- edited therapy, for a rolling review with the FDA. Earlier this year, the US Food and Drug Administration (FDA) approved the first potentially curative gene therapy to treat beta-thalassemia.

Food and Drug Administration 52

Food and Drug Administration Side effects Patients FDA 52

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). CAR T-cell Therapy and its side effects [Internet]. References National Cancer Institute.

Food and Drug Administration 110

Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

NOVEMBER 4, 2022

tumour effects. Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. Taxane therapy is an established, highly effective cornerstone in oncology treatment.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Patients 98

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness. The FDA’s action plan.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. References Hendrix S.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97