News
The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
FEATURED STORIES
Digitization enables each drug to have a software-enhanced version optimized for individual patients.
The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease.
A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients.
Job Trends
Takeda announced that the U.S. Food and Drug Administration has approved ADZYNMA for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
THE LATEST
Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.
In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q1 job market performance, layoffs and administration decisions impacting the workforce.
In the company’s first-quarter earnings call Tuesday, J&J CEO Joaquin Duato said there’s a better way to encourage drug manufacturing in the U.S. than President Donald Trump’s threatened pharma tariffs.
Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for.
J&J opened Q1 2025 pharma earnings Tuesday, reporting sales of $21.9 billion and diluted earnings per share of $4.54. The medicines unit provided $13.9 billion while the medtech unit generated the remaining $8 billion.
According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion label expansion opportunity for Camzyos.
At the heart of the licensing deal is CUE-501, a bispecific molecule that can selectively deplete B cells to address autoimmune and inflammatory conditions.
Trump could use the findings of the probe to impose certain trade restrictions on pharma products, including tariffs.
In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.
Viking Therapeutics enjoyed a nice share rally on the news that rival Pfizer is discontinuing obesity candidate danuglipron. But the biotech has a long way to go to recover after six straight months of decline.