Browsing Tag
US Food and Drug Administration
333 posts
ExeGi Pharma’s EXE-346 receives FDA orphan drug designation for pouchitis treatment
ExeGi Pharma, a biotechnology company headquartered in Rockville, Maryland, has announced that its live biotherapeutic product (LBP), EXE-346,…
FDA grants emergency use authorization for Bamlanivimab to treat Covid-19
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for bamlanivimab (LY-CoV555), a neutralizing…
Janssen seeks expanded approval for DARZALEX in treating AL amyloidosis
Janssen Pharmaceutical Companies of Johnson & Johnson has recently submitted a Type II variation application to the European…
OliX Pharmaceuticals seeks FDA nod for phase 2a trial of OLX10010
OliX Pharmaceuticals, a South Korean pharma company, has submitted an investigational new drug (IND) application to the US…
Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer
Kazia Therapeutics, an Australian biotech company, has secured the rare pediatric disease designation (RPDD) for paxalisib (formerly GDC-0084)…
Bayer gets Lampit FDA approval for Chagas disease in pediatric patients
Lampit FDA approval : Bayer has bagged approval for its antiprotozoal medication Lampit (nifurtimox) from the US Food…
Ascentage Pharma gets FDA ODD for APG-2575 in Waldenström macroglobulinemia
Ascentage Pharma has been granted orphan drug designation (ODD) for its Bcl-2 inhibitor APG-2575 from the US Food…
CenterLab’s anti-diabetic drug candidate CS02 meets primary endpoint in phase 2 trial
Taiwanese pharma company Center Laboratories (CenterLab) said that its anti-diabetic drug candidate CS02 has met the primary endpoint…
ViiV Healthcare bags Rukobia FDA approval for HIV patients with limited treatment options
Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia…
Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial
Covid-19 stem cell clinical trial : Celltex Therapeutics has been given the clearance by the US Food and…