Unicycive OLC received a second FDA CRL over third-party manufacturing deficiencies. The case shows why CMC risk now drives ...

AlzeCure licensed NeuroRestore ACD856 to QuantumCell in a deal worth over $2.2B. The real story is not proof, but Alzheimer’s ...

Viridian’s Lumvoa approval breaks Tepezza’s TED monopoly. Inside the label, Phase 3 data, safety risks, payer hurdles and ...

FDA Issues CRL to Sobi for NASP in Uncontrolled Gout, but the letter did not attack the clinical case. It attacked ...

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 ...

Viridian’s Lumvoa Broke Tepezza’s Monopoly. Now Viridian Has to Prove It Can Sell | Witfire Elite View Witfire Elite Competitive Strategy Case Studies Launch Execution Long Read Pharma Market Case ...

Phase 3 Data, Capital Structure and the Cost of Independence Revolution Medicines has not eliminated acquisition interest. It has eliminated the financial urgency that could force it to accept an ...

Four months after FDA refused to file Moderna’s application, its vaccine advisers unanimously supported its benefit-risk profile in adults aged 50–64 and again in adults aged 65 and older. Same ...

GSK’s $10.6B Nuvalent acquisition is more than an oncology deal. It is a pre-approval bet on zidesamtinib, neladalkib, and two FDA decision dates in 2026.

FDA rejected Replimune’s RP1 despite a 34% response rate in advanced melanoma. The rejection centered on single-arm trial design and evidence standards.