CAR T cells have been groundbreaking for the treatment of B-cell cancers. But 8 years after Kymriah (tisagenlecleucel, ...
Parkinson’s disease is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a ...
Uniqure NV is the latest firm to get caught between the FDA’s shifting demands for “gold standard” science and regulatory flexibility for rare disease therapies. The company disclosed in its latest ...
Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral ...
Targeting an ultrarare disease affecting about 250 U.S. residents, Immedica Pharma AB’s Loargys (pegzilarginase) won accelerated FDA approval to treat hyperargininemia in those ages 2 and older with ...
The massive cuts to science, global health, and HIV programs that unfolded in 2025 triggered a crisis with worldwide repercussions. The dissolution of USAID, the shutdown of PEPFAR, and the suspension ...
The effects of aging pose an additional challenge for people with HIV due to the neurological and psychological consequences ...
The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a ...
Targeting rare cardiomyopathy conditions with no approved disease-modifying therapies, Atrium Therapeutics Inc. started operations in San Diego, assuming the public listing and technology once held by ...
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in ...
Breezebio Inc., formerly known as Genedit Inc., has closed $60 million in series B financing to advance its first internal therapeutic programs toward the clinic and to continue expansion of the ...
Prospect Therapeutics Inc. has synthesized new substituted tricyclic derivatives acting as tyrosine-protein kinase JAK1 and non-receptor tyrosine-protein kinase TYK2 inhibitors.
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