Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Food and Drug Administration 98

Food and Drug Administration FDA Marketing Pharmaceutical 98

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Are you hiring?

FDA 52

FDA Food and Drug Administration Physicians Safety 52

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 114

Medicine Food and Drug Administration Doctors Government 114

European Pharmaceutical Review

OCTOBER 19, 2023

The Investigational New Drug (IND) application for Intellia Therapeutics’ in vivo CRISPR-based candidate NTLA-2001, has been cleared as a gene editing therapy for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) in the US. This supports NTLA-2001’s potential as a single-administration therapeutic.

Food and Drug Administration 90

Food and Drug Administration Medicine Food Pharmaceutical 90

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

pharmaphorum

SEPTEMBER 13, 2022

2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Today, the bone marrow donor registry comprises more than 39,527,166 donors and 804,246 cord blood units.

Food and Drug Administration 84

Food and Drug Administration Patients Engineering Physicians 84

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US. from 2001 to 2022.”

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Competition 98