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Bringing patients into the drug development process early has proven to save time, money and resources.
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The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
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As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.
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Overall, the top 16 largest pharmaceutical companies spent $159 billion on research and development in 2025, compared to $165 billion the year prior. Here’s where all that cash went at companies like Johnson & Johnson, Amgen and Pfizer.
Trace Neuroscience, a member of BioSpace’s NextGen Class of 2026, has learned from the success of Biogen’s Qalsody and aims to bring more treatment options to the ALS community.
While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
Like its pharma peers, Novartis is pouring money into Chinese operations, including expansions and upgrades at an existing manufacturing facility.
Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.
Gilead’s median employee compensation in 2025 was $238,979. Daniel O’Day’s compensation package is 119 times larger.
Following last month’s $7.8 billion purchase of CAR T biotech Arcellx, Gilead’s dealmaking train chugs along with yet another acquisition—this time securing Ouro Medicines’ pipeline of T cell engagers for inflammatory diseases.
The biotech industry needs to stop waiting for a rebound. The pandemic changed everything, though not in the ways most people think.
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.