Vial

MAY 13, 2024

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. A 2016 study by Sertkaya et al. For Phase II trials, the average clinical trial lengthened from 37 to 41 months between the two periods.

Clinical Trials 52

Clinical Trials Trials Drug Development Production 52

Elrig

APRIL 29, 2024

I pursued a degree in Pharmacy from the University of Murcia to become a qualified Pharmacist, followed by an MSc in Cancer Pharmacology at London Metropolitan University. Miguel Gancedo Rodrigo Miguel Gancedo Rodrigo Research Investigator, Isomorphic Labs My name is Miguel, and I’m from Murcia, Spain.

Bioinformatics 59

Bioinformatics Drugs Molecular Biology Cell Based Assays 59

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA 40

FDA Trials Therapies Regulations 40

Codon

FEBRUARY 13, 2024

Phage therapies are sold at a pharmacy in Georgia. Credit: Tom Ireland Garafolo believes that if any of these new approaches to phage therapy can lead to just one impressive result in a major trial, it could open the floodgates to robust investment in phage therapy from the world’s biggest drug makers.

Therapies 135

Therapies Virus DNA Clinical Trials 135

Agency IQ

OCTOBER 27, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

DECEMBER 1, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40