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DS-9606 was supposed to be the first antibody-drug conjugate in Daiichi Sankyo’s line of anti-cancer assets to use a modified pyrrolobenzodiazepine payload.
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AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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Following disappointing results in a mid-stage social anxiety disorder study, the Australian biotech’s investigational ion channel modulator demonstrated promising effects in patients with post-traumatic stress disorder.
After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
The FDA will kick off October with an advisory committee meeting for Amgen’s Lumakras and target action dates for Alnylam’s patisiran and Bristol Myers Squibb’s Opdivo.
If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.
The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.
Non-small cell lung cancer patients treated with the drug combination saw a statistically significant and clinically meaningful improvement in progression-free survival compared to AstraZeneca’s osimertinib.
The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.
After an FDA advisory committee voted 17-1 against approving NurOwn last month, BrainStorm executives Wednesday laid out a potential path forward for the experimental amyotrophic lateral sclerosis treatment.
As the incoming CEO of Vicore, Mousa is ready to rally for fresh investment to advance cures for respiratory conditions.