Pulnovo reports two U.S. procedures in the PULSE-LHD trial. The estimated 750-participant IDE study uses a sham control; no ...

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 ...

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 ...

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 ...

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 ...

A bright clinical concept image showing the stabilizer ceiling in amyloidosis, where modern background therapy reduces the detectable benefit of add-on drugs. HELIOS-B cleared its endpoint.

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 ...

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 ...

The ravulizumab ARTEMIS trial has been terminated at 555 patients. Read alone it is one failed study. Read against the registry it is the sixth attempt to take a rare-disease drug into a large ...

4SigHT is formally a long-term observational study. Its timing points to something larger: Tanabe is building a Japanese evidence moat before Bristol Myers Squibb brings a self-administered rival into ...

Lumvoa Broke Tepezza’s Monopoly. Now Viridian Must Prove It Can Sell. Viridian entered a $1.9 billion market at price parity with a shorter infusion course and a broader label. Two months earlier, ...