Merck's LIPFENDRA (enlicitide), the first FDA-approved oral PCSK9 inhibitor, approved 16 July 2026 at a list price of $315 for a 30-day supply. Amgen's Repatha (evolocumab) is already available for ...

Oral PCSK9 Inhibitor Approved: LIPFENDRA Price vs Repatha Witfire Elite Cardiometabolic Pricing & Access Market Case Studies Long Read Pharma Market Case Studies Witfire Elite View Oral PCSK9… ...

Oral PCSK9 Inhibitor Approved: LIPFENDRA Price vs Repatha Witfire Elite Cardiometabolic Pricing & Access Market Case Studies Long Read Pharma Market Case Studies Witfire Elite View Oral PCSK9… ...

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Oral PCSK9 Inhibitor Approved: LIPFENDRA Price vs Repatha Witfire Elite Cardiometabolic Pricing & Access Market Case Studies Long Read Pharma Market Case Studies Witfire Elite View Oral PCSK9… ...

4SigHT is formally a long-term observational study. Strategically, its timing points to something larger: Tanabe is building a Japanese real-world evidence moat before Bristol Myers Squibb brings a ...

Oral PCSK9 Inhibitor Approved: LIPFENDRA Price vs Repatha Witfire Elite Cardiometabolic Pricing & Access Market Case Studies Long Read Pharma Market Case Studies Witfire Elite View Oral PCSK9… ...

Bright biotech illustration for Unicycive’s OLC CRL, showing nanoparticle formulation, manufacturing control strategy, FDA quality risk and CDMO execution failure. The FDA did not reject Oxylanthanum ...

Reuters reported that Viridian plans to launch Lumvoa immediately as its first commercial product, and that the company expects to price the drug at parity with the existing approved IGF-1R therapy on ...

FDA gave Sobi a Complete Response Letter for NASP in uncontrolled gout, but the letter did not attack the clinical case. It attacked manufacturing control, CMC readiness and contract manufacturing ...

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 ...