The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

Excitement is building around a new weight loss drug, CagriSema, which is expected to surpass the effects of popular drugs ...

PharmaTher Holdings Ltd. (the "Company” or "PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification ...

The path from a scientist’s initial idea to a new medicine that can save lives is a complex and often lengthy process. It ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.

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

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

Jump in fees for new drug applications expected An industry expert, who works in one of the top pharma companies of India, ...

This study introduces a novel lignin-based hydrogel with controlled release and enhanced mechanical strength, leveraging ...

AstraZeneca Plc raised its annual forecast, driven by strong demand for its blockbuster cancer drugs, and revealed a plan to ...