Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA fili | ...

In a merger of rare disease specialists, BioMarin has agreed to acquire Amicus Therapeutics for $4.8 billion. The California ...

As the FDA steadily churns out a stream of untitled letters chastising pharmaceutical advertisers’ direct-to-consumer ...

Regeneron has had its hands full this year contending with regulatory | Alvotech and Teva's Eylea biosimilar has been under FDA review for much of this year. Back in February, the companies said they ...

Cybin is shedding its old identity, evolving into Helus Pharma as part of changes that will see its shares move to a different stock exchange.

As 2025 closes, biopharma and healthcare are learning to live on shifting ground. | Fierce reporters break down the forces that shaped biopharma and healthcare in 2025 and what lies ahead in 2026.

Pharma marketers enter 2026 asking where DTC fits in the DTP era.  | Pharma marketers enter 2026 asking where DTC fits in the ...

“Healthcare and pharma are steadily moving past a TV-first mindset. While linear TV made up more than 30% of the industry’s ...

In the last Fierce Pharma Asia weekly news roundup of 2025, Daiichi Sankyo scored a key FDA approval for ...

Medtronic initially secured FDA clearance for the MiniMed 780G pump for people with Type 1 diabetes in early 2023. This past ...

Insmed has come up short in its attempt to expand its newly approved potential blockbuster Brinsupri into a new indication. | ...

J&J has hypothesized that subcutaneous absorption of the drug may potentially enhance immune-mediated anticancer activity.