News
With a pair of Phase III trial flops, Ultragenyx will explore cost reductions as analysts turn attention to an upcoming Angelman syndrome readout.
FEATURED STORIES
A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
THE LATEST
Madrigal will study SYH2086 in combination with Rezdiffra for metabolic dysfunction-associated steatohepatitis, aiming for clinical trials in early 2026.
Long-term data presented at the Alzheimer’s Association International Conference show Leqembi can help patients stay in the earlier stages of Alzheimer’s disease as compared to the condition’s natural progression.
Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years.
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
CEO Emma Walmsley maintained that continued investment in the U.S. is a priority for the pharma to ensure its medicines for the country are supplied domestically.
Against steep odds and well-established paradigms, these four companies have successfully been commercializing their products on their own.
Though nerves abound for funders and founders in the industry, money continues to flow into startups, sometimes in eye-popping numbers. BioSpace rounds up the biggest raises so far this year.
Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.
Pascal Soriot’s comments came during AstraZeneca’s Q2 earnings call in regard to President Donald Trump’s newly announced European pharma tariffs. The company also announced estimate-beating earnings, with its cancer portfolio driving earnings despite clinical roadblocks.