New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. 88 (12): 5389–5398.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Alta Sciences

SEPTEMBER 20, 2023

In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ nonclinical site in Columbia, MO. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms.

Virus 40

Virus Clinical Pharmacology FDA Approval Drugs 40

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. This represents about a 44% increase over the number of NMEs approved in the previous fiscal year , which was among the lowest years for approvals in the last decade. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Production 52