News
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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The Janssen Pharmaceutical Companies of Johnson & Johnson announced it will present data from six company-sponsored studies in support of their respiratory syncytial virus adult vaccine candidate at the Eighth European Scientific Working Group on Influenza meeting.
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Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.
Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
Merck finalized the acquisition of immune-focused Prometheus Biosciences for approximately $10.8 billion, picking up mid-stage ulcerative colitis and Crohn’s asset.
The Supreme Court extended the stay deadline to Friday at midnight to keep mifepristone on the market in the interim without conditions.
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets.
Aer’s inhaled formulation targets the mucus plugs obstructing COPD patients’ airways.
The regulator found no issues with mirikizumab’s clinical or safety data.
New therapeutics for Major Depressive Disorder could change the treatment landscape and give patients more options.