Philippine FDA CPR renewal guidance confirms when an expired medical-device CPR remains valid during review and which records ...

Alevia-B combines paracetamol with vitamins B1, B6 and B12. Its 2025 Philippine FDA record predates PascualLab's current pain ...

RENGEVITY-201 trial begins Phase 2 testing of pegrizeprument against tacrolimus in kidney transplantation. We examine its ...

Witfire Elite · Clinical Catalysts · Trial Design Audit Pulnovo says two U.S. participants have undergone PULSE-LHD procedures at Henry Ford. The registry estimates total enrolment at 750, including ...

No efficacy concern. No safety concern. A launch Sobi valued at SEK 4–6 billion, stopped by a third-party facility. And it was the second of three manufacturing-driven rejections the FDA issued in ...

Bright biotech illustration for Unicycive’s OLC CRL, showing nanoparticle formulation, manufacturing control strategy, FDA quality risk and CDMO execution failure. No safety concern. No efficacy ...

AlzeCure did not prove ACD856 works in Alzheimer’s patients. It proved that early safety, brain exposure and a novel mechanism can still move a small Nordic biotech into a multibillion-dollar ...

Put this method on a file you are actually deciding. Witfire Elite provides pharmaceutical due diligence services built on the method used in every brief published here: every figure traced to a ...

Merck priced the first oral PCSK9 inhibitor at $10.50 a tablet. Amgen has been selling Repatha, in cash, for roughly eight dollars a day since October. That is the whole trade in two lines, and most ...

RP1 showed a roughly one-in-three response rate, durable activity, and a favorable safety profile in anti-PD-1-failed advanced melanoma. The FDA rejected it anyway — not because the drug had obviously ...

Bright scientific image illustrating eplontersen TTR silencing in transthyretin amyloid cardiomyopathy, cardiac amyloid burden and the challenge of adding a silencer to stabilizer therapy. HELIOS-B ...