FDA
The FDA on Tuesday extended the label for Takeda’s immune globulin infusion as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy.
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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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The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
Pfizer announced the FDA has granted its combinatorial therapeutic ervogastat/clesacostat Fast Track Designation that is intended for the treatment of NASH with liver fibrosis.
Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Ocugen introduced NeoCart, which is designed to repair full-thickness lesions of the knee cartilage in adults, as a Phase III cell therapy platform technology.
The approval marks the first for EoE, a chronic, progressive type 2 inflammatory disease that damages the eosinophilic esophagitis and prevents it from working properly.
Sanofi, AstraZeneca, Avillion and Diadem recently announced clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.