Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...

must submit an NDS within 12 months of filing a New Drug Application (NDA) in the US. This requirement is established by ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem ...

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung ...

NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing ...

The marketing applications with the EMA and FDA are for J&J and partner Genmab's Darzalex Faspro version of the anti-CD38 ...

To celebrate Science Week, we’ve put together a bumper list of 25 scientists based in Ireland who are innovating across STEM.

Q3 2024 Earnings Call Transcript November 9, 2024 Operator: Good day, and welcome to the Third Quarter 2024 Harvard Biosciences Inc. Earnings Conference Call. [Operator Instructions] As a reminder, ...

Children were given electroconvulsive therapy and sedatives as punishment - and it wasn't limited to Lake Alice.

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

I have long held the belief that digital therapeutics will be prescribed alongside drugs to improve patient outcomes, leading ...