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

SigHT is formally a long-term observational study. Strategically, its timing points to something larger: Tanabe is building a ...

Revolution Medicines built a $4.3B liquidity wall around daraxonrasib. Inside its Phase 3 data, Royalty Pharma terms, ...

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.

The Witfire Elite Pharma News is a pharma business and healthcare intelligence publication focused on pharmaceutical markets, regulatory developments, biotech innovation, healthcare startups, ...

GLP-1 Market: The obesity and diabetes drug race is becoming one of the biggest business stories in global pharma. Reuters reported that analysts now estimate global obesity drug sales around USD 105 ...

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

A data-heavy Witfire Breaking Case Study on Fulcrum’s pociredir collapse, FDA’s PRC2 class-risk logic, Tazverik’s blood cancer signal, sickle-cell drug development, and biotech valuation risk. Fulcrum ...