Sales of the company’s copycat to J&J’s blockbuster medicine reached $150 million in the first quarter, adding to a surge in ...

The FDA pushed back its decision date on Cytokinetics’ heart drug, while AstraZeneca got Phase 3 results that could help it ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Drugmaker executives have projected confidence they can mitigate the impact of any levies Trump imposes on the industry. Yet ...

Siren Biotechnology is trying to raise $5 million via the type of crowdfunding round that’s rarely used by young drugmakers.

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in ...

The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core ...

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal ...

Deals with Hims & Hers, LifeMD and Ro follow dismissal of a lawsuit that challenged the FDA's determination Wegovy is no ...

Trium Capital is the latest firm to push a biotech “zombie” to shut down, claiming in a regulatory filing there is more ...

The drugmaker absorbed additional tariff-related costs in the first quarter, but has taken steps to lower the financial ...