FDA
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
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After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
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In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
The FDA’s approval of Eli Lilly’s obesity drug Zepbound intensifies an already heated battle with Novo Nordisk’s Wegovy in the lucrative weight-loss drug market, as other drugmakers hope to get a piece of the action.
Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.
The biopharma’s Adzynma, a human recombinant ADAMST13 therapeutic, is the first approved therapy for the ultra-rare clotting disorder congenital thrombotic thrombocytopenic purpura.
The oral targeted therapy, now sold under the brand name Fruzaqla, is approved for adults with metastatic colorectal cancer who have received certain previous treatments for the disease.
Lilly’s Zepbound (tirzepatide) injection is the first and only approved treatment that activates two incretin hormone receptors, GIP and GLP-1, to treat obesity and excess weight.
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
Pfizer, Moderna, Novavax and more are working to combine preventative shots for COVID-19, flu, RSV and other illnesses. Will convenience be enough to overcome vaccine fatigue?