2016 Food and Drug Administration Safety 
European Pharmaceutical Review
JUNE 29, 2023
The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.
European Pharmaceutical Review
JULY 4, 2024
In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?
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European Pharmaceutical Review
FEBRUARY 22, 2023
Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.”
Pharmaceutical Technology
NOVEMBER 3, 2022
The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.
Clarivate
MAY 24, 2022
Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].
Pharmaceutical Technology
APRIL 6, 2023
Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. The investigational drug has been developed for treating patients with mesothelioma, a rare type of cancer that impacts abdominal cavities or the chest lining.
Pharmaceutical Technology
NOVEMBER 30, 2022
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The egress of the drug itself (a leakage) is also of critical importance.
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