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Regulatory Intelligence & Drug Approvals2 months agoPharmaEssentia’s Besremi receives FDA approval for ET
This marks the first FDA-approved treatment for ET in nearly 30 years. The approval is based on data from the global Phase III SURPASS ET trial,...
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Regulatory Intelligence & Drug Approvals2 months agoBreathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.
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Regulatory Intelligence & Drug Approvals2 months agoMFN deals, Lilly takeout, FDA pick Overton — a BioCentury podcast
BIOCENTURY | POLITICS, POLICY & LAWMFN DEALS, LILLY TAKEOUT, FDA PICK OVERTON — A BIOCENTURY PODCASTMonday’s drug pricing reveal by White House short on U.S. biopharmas
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Regulatory Intelligence & Drug Approvals2 months agoBIO 2026: Are we entering the ‘golden era’ of women’s health?
For years, advocates have pushed for more research and investment in women’s health. Now, it may be paying off. “I’m excited about the medicine […] The...
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: We’re reading about drug pricing deals, a new cancer therapy approval, and more
In today's Pharmalittle newsletter, drug pricing deals, a new cancer therapy approval, and more of the latest pharma headlines.
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Regulatory Intelligence & Drug Approvals2 months agoTakeda, Protagonist score broad FDA nod in rare blood cancer, setting up $2B opportunity
The approval of rusfertide—now to be branded Mimrylo—for polycythemia vera marks a key win for Takeda, which now has crossed the FDA finish line for two...
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Regulatory Intelligence & Drug Approvals2 months agoAna Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F,...
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: FDA approves Protagonist and Takeda’s drug for rare blood cancer
Mimrylo, from Takeda and Protagonist, is a new kind of treatment for the blood cancer polycythemia vera.
Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
Genmab’s cancer bispecific delivers early OS win in ‘exceedingly positive’ Phase 3 readout
STAT+: HHS moves to allow compounding of some unapproved peptides
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
