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Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
FEATURED STORIES
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month.
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
Companies have claimed improvements to yield, batch consistency and output while acknowledging the risks and challenges created by the technology.
LB Pharma will test the IPO market to seek funding for a Phase III-ready schizophrenia asset.
The deal extends AbbVie’s commitment to the psychedelics space and depression, after emraclidine’s high-profile flop in schizophrenia last November.
Arnatar is developing ART4, an antisense oligonucleotide that ups the expression of its target protein to treat a rare disease called Alagille syndrome.
Thousands of employees across the Department of Health and Human Services are set to lose their collective bargaining rights in a move that American Federation of Government Employees national president Everett Kelley called “illegal and immoral.”
Earlier this month, the FDA backed off on a pause in shipments of the chikungunya vaccine Ixchiq to older adults. Now, the regulator has reversed course.
The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and losers. Here are five molecules that never made it to the market.