FDA Novel Drug Approvals: May 2022
There were two novel small molecules approved in May 2022: And one novel large molecule approval: This deep dive explores each drug in more detail, including the industry context, the clinical data, the target rationale, mechanisms of action, and drug origins. See our overview of all 36 of the novel small molecule and large molecule…
2021 FDA Endocrinology Approvals: Novel Small Molecules Deep Dive
In 2021, the FDA approved two new drugs for endocrinology-related indications, including severe hypoglycemia in diabetes, and chronic kidney disease (CKD) associated with type 2 diabetes. This article and slide deck explores each in more detail, including but not limited to their: target rationale discovery disease context original patents key clinical data pharmacokinetics industry history
The 2021 New Drug Approvals for Immunological Diseases: Deep Dive
In 2021 the FDA approved four new drugs for various immunological diseases, including a molecular glue, the first drug approved for AAV in a decade, and a ROCK kinase inhibitor originally investigated for cancer. This article and slide deck explores each in more detail, including but not limited to their: mechanisms of action target rationale…
FDA Novel Drug Approvals: April 2022
There were two novel small molecules approved in April 2022: This deep dive explores each drug in more detail, including the industry context, the clinical data, the target rationale, mechanisms of action, and drug origins. See our overview of all 36 of the novel small molecule and large molecule FDA approvals for 2022 here.
FDA Novel Drug Approvals: March 2022
This article reviews the three novel drugs approved by the FDA in March 2022 in detail. together with Dr. Naveed Yasin, Jesse Keicher, Dr. Jennifer Huen, and Dr. Adrian Parodi Small molecules: Large molecule: Some interesting snippets about each drug from our report: The full Premium report below summarizes for each drug: See our overview…
2021 Neurology Drug Approvals: Small Molecule Deep Dive
The FDA approved five novel small molecule drugs in neurology in 2021. Addressing a range of conditions from ADHD to relapsing MS, the 2021 neurology drug approvals are: atogepant (Qulipta): calcitonin gene-related peptide (CGRP) receptor antagonist ponsimod (Ponvory): selective sphingosine-1-phosphate (S1P) receptor 1 (S1PR1) modulator samidorphan (Lybalvi): novel mu opioid receptor (MOR) antagonist (olanzipine combo)…