Pharmaceutical
PopSci
Regulation
The 25-Year FDA Novel Drug Approval and Indication Matrix
By analyzing historical data from the FDA’s Center for Drug Evaluation and Research (CDER) alongside prominent industry benchmarks over the past 25 years (2001 to 2025), a clear story emerges. CDER approved 951 novel drugs during this period. However, the...
Pharmaceutical
PopSci
Regulation
The basics about nonclinical toxcitiy study director
What Is a Nonclinical Toxicity Study Director? Before any experimental medicine enters a human body in a Clinical Trial, it must pass a battery of rigorous safety evaluations in the laboratory. At the center of this...
Chemical
Pharmaceutical
Sci&Tech
How bench scientist select a reactionsolvent (part-3/end)
When you are pushing a reaction toward a larger pilot-plant scale, or just trying to get enough material for the next stage of testing, you run into the gritty reality of process development: dealing with uncooperative,...
Biotech
Molecule Digest
Pharmaceutical
Molecule Digest:Rasonque
1. What is Rasonque? Rasonque (Daraxonrasib, RMC-6236) is an oral, first-in-class, multi-selective tri-complex “molecular glue” inhibitor designed to selectively target and shut down the active, GTP-bound (“ON”) state of RAS proteins. Developed by Revolution Medicines, it gained breakthrough prominence...
Pharmaceutical
Sci&Tech
How to Solve Metabolic Stability Issues in Early Drug Discovery
You’ve designed a molecule with exceptional oral absorption and carefully tuned its physical chemistry to hit the optimal tissue distribution sweet spot. Yet, when you dose it in a rodent model, the drug’s systemic concentration plummets...
Chemical
Pharmaceutical
Sci&Tech
How bench scientist select a reactionsolvent (part-2)
Once you move past simple substitutions and start building carbon-carbon or carbon-nitrogen bonds, the solvent stops being a passive host and becomes a critical referee. In this phase of process chemistry, your choice of solvent is...
Pharmaceutical
Sci&Tech
How to Solve the Drug Distribution Issue in Early Discovery
You’ve optimized your lead molecule for flawless oral absorption and verified that it binds its target with nanomolar potency in biochemical assays. But when you dose it in vivo, the therapeutic effect is completely absent. You check...
Pharmaceutical
Sci&Tech
How to solve oral absorption issues in early drug discovery
1. What is Absorption? In drug discovery, absorption is the process by which a drug transitions from its site of administration (most commonly the gastrointestinal lumen after oral dosing) into the systemic circulation. To achieve this, a dissolved drug...
Chemical
Pharmaceutical
Sci&Tech
How bench scientist select a reactionsolvent (part-1)
You look up a prep in the literature, you see the authors used DCM, so you grab the DCM bottle without a second thought. If the reaction fails, you blame the catalyst, you question the purity...
Industry
Pharmaceutical
Regulation
Navigating the Regulatory Evolution of NAMs In 2026
The pharmaceutical industry is at the threshold of a historic transformation in how medicine safety is evaluated. For decades, animal models were regarded as the “gold standard” for supporting efficacy and safety prior to human clinical...