Regulation

AnHeart, NewG Lab receive orphan drug designation in Korea for NSCLC therapy

AnHeart Therapeutics and NewG Lab Pharma subsidiary NewG Lab Therapeutics have received orphan drug designation in Korea for the next-generation tyrosine kinase inhibitor (TKI), taletrectinib, to treat advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

US FDA approves Revance’s Daxxify for injection to treat frown lines

The US Food and Drug Administration (FDA) has approved Revance Therapeutics’ Daxxify (DaxibotulinumtoxinA-lanm) for injection to temporarily improve moderate to severe frown lines (glabellar lines) in adults.

China’s NMPA approves AstraZeneca’s Forxiga to treat chronic kidney disease

China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adult patients who are at risk of progression with and without type-2 diabetes (T2D).

Boehringer Ingelheim receives FDA approval for GPP flares therapy

Boehringer Ingelheim has received the US Food and Drug Administration (FDA) approval for its monoclonal antibody, spesolimab, to treat adult patients with generalized pustular psoriasis (GPP) flares.

Amneal submits NDA to US FDA for Parkinson’s disease treatment

Amneal Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for IPX203 to treat Parkinson’s disease (PD).

OKYO Pharma plans to file IND with US FDA for Dry Eye Disease therapy

OKYO Pharma has announced plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for OK-101 to treat Dry Eye Disease (DED), in the fourth quarter (Q4) of this year.

EC approves Novartis’ Scemblix for chronic myeloid leukemia treatment

The European Commission (EC) has approved Novartis’ Scemblix (asciminib) to treat chronic myeloid leukemia (CML) in adult patients.

Novavax gets MHRA expanded conditional marketing authorisation for Nuvaxovid

Novavax has received expanded conditional marketing authorisation (CMA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373).

Japan approves AstraZeneca’s Ultomiris for generalised myasthenia gravis

AstraZeneca has received the Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Ultomiris (ravulizumab) to treat generalised myasthenia gravis (gMG) in adult patients.