European Pharmaceutical Review

FEBRUARY 14, 2023

Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Food and Drug Administration 105

Food and Drug Administration Medicine Safety Consulting 105

Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. In the pirtobrutinib safety cohort, only 2.6% of patients discontinued treatment due to adverse events.

FDA 59

FDA Patients Safety Pharmaceutical 59

Pharmaceutical Technology

AUGUST 16, 2022

Enhertu has already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma, with annual sales for these indications alone expected to exceed $1.3bn by 2028.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

Medico Reach

OCTOBER 17, 2022

million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

PM360

SEPTEMBER 21, 2023

Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market.

Management 105

Management Manufacturing Sales Competition 105

Clarivate

AUGUST 27, 2024

FDA approval in January 2024. In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. Boston Scientific Corp. s Farapulse.

Marketing 52

Marketing Competition FDA Electronics 52

Pharmaceutical Technology

AUGUST 24, 2022

CAGR between 2020 and 2028. FCM data are used to make clinical decisions around safety, efficacy, and pharmacodynamics. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3. The importance of validation.

Transportation 52

Transportation Patients Marketing Safety 52