Capricor’s PDUFA Extension Makes the Endpoint Case Central to Deramiocel’s Review
Capricor Therapeutics announced on August 24 that FDA extended the target action date for its Biologics License Application for deramiocel,…
Author: Jane Aubrey
Jane Aubrey brings over a decade of experience as a clinical researcher to her reporting on drug development and regulatory pathways. At The Biotech Codex, she breaks down complex trial data and analyzes the pipeline strategies of both emerging biotechs and legacy pharma giants. Her coverage demystifies the arduous journey from bench to bedside, keeping industry professionals informed on the latest therapeutic breakthroughs.
Genglycos Brings the First Approved Therapy to GSDIa—But Its Accelerated Approval Is Only the Beginning
The FDA’s accelerated approval of Genglycos is a landmark for patients with glycogen storage disease type Ia, a rare inherited…
FDA Feedback Gives Oncolytics a Potential Shortcut—But REO 033 Still Must Earn Its Pivotal Expansion
Oncolytics Biotech has secured FDA written feedback that could make the development path for pelareorep in metastatic colorectal cancer more…
How BioLayer is Rewriting the Data Supply Chain for Healthcare AI
As consumer health agents and biomedical AI models accelerate, the central economic and ethical question facing the industry is no…
AbelZeta’s Prizlon-cel IND Reopens the Question of How CAR-T Can Work After CAR-T Failure
AbelZeta Pharma has received FDA clearance to begin U.S. clinical development of Prizlon-cel, an anti-CD20/CD19 bispecific CAR-T therapy for relapsed…
Zenbexus Opens a New Myeloma Drug Class, but the Confirmatory Test Still Lies Ahead
The FDA’s accelerated approval of Bristol Myers Squibb’s Zenbexus gives multiple-myeloma treatment a new class of medicine and creates an…
Manufacturing Stumble: FDA Rejects ITM Radiopharma’s Neuroendocrine Tumor Therapy
In a stark reminder of the immense logistical complexities surrounding radiopharmaceuticals, the U.S. Food and Drug Administration (FDA) has issued…
Eli Lilly Escalates Obesity War, Offers Early Access to Next-Gen GLP-1 Retatrutide
The battle for dominance in the lucrative obesity drug market is entering a new and aggressive phase. Eli Lilly has…
FDA Expands Casgevy Gene Therapy Approval to Children as Young as Two with Sickle Cell Disease
In a monumental milestone for pediatric hematology, the U.S. Food and Drug Administration (FDA) has expanded the approval of Casgevy,…
Third Time’s the Charm: FDA Finally Approves Replimune’s Melanoma Therapy
In a testament to clinical persistence, the U.S. Food and Drug Administration (FDA) has officially approved Replimune’s novel melanoma therapy,…
Merck’s Q2 Earnings: Oncology Dominance Masks Looming Patent Cliff Anxiety
Merck & Co. (MRK) reported its second-quarter 2026 financial results, delivering a performance that simultaneously showcased the unmatched commercial power of…