European Pharmaceutical Review

JULY 13, 2023

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). Expert Review of Clinical Pharmacology. Plant cannabinoids: a neglected pharmacological treasure trove. British journal of pharmacology. 2023 Mar 4;16(3):257-66. Mechoulam R.

Medical 87

Medical Food and Drug Administration Pharmacology Medicine 87

European Pharmaceutical Review

AUGUST 23, 2022

“Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

Food and Drug Administration 71

Food and Drug Administration Pharmacology Prospecting Medical 71

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs.

Food and Drug Administration 76

Food and Drug Administration Pharmaceutical products FDA Pharmacology 76

European Pharmaceutical Review

APRIL 13, 2023

The US Food and Drug Administration (FDA) has decided to fast-track psilocybin for depression, with full support from President Biden’s administration. Pharmacological Reviews. Additionally, several US and Canadian states have legalised or decriminalised magic mushrooms. References Nichols DE. Psychedelics. 2016;68(2):264–355.

Medicine 117

Medicine Food and Drug Administration Doctors Government 117

European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Engineering Pharmacology 79

Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. The approval also includes clearance for a Phase I clinical trial protocol of NXP900.

Food and Drug Administration 52

Food and Drug Administration Pharma FDA Pharmacology 52

Evolve Your Success

OCTOBER 24, 2023

They understand the American and European requirements of the FDA and the EU. I worked at a now-defunct pharmaceutical company in San Diego and did benchtop research in a couple of different pharmacology models for two years. I was using all I knew about biology, physiology, and pharmacology. Let’s switch gears a little bit.

Sales 64

Sales Medical Manufacturing Medical sales 64

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

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.

Food and Drug Administration 79

Food and Drug Administration Safety Patients Leads 79

Pharmaceutical Technology

MARCH 1, 2023

Recently, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Paxlovid, an inhibitor for the first protease of SARS-CoV-2 (Mpro). The licensed technology specifically includes small molecules found to be efficient PLpro inhibitors.

Biopharma 59

Biopharma Food and Drug Administration Pharmacology Food 59