Home » Posts tagged with » US Food and Drug Administration
Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer

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) from the US Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG). Diffuse intrinsic pontine glioma is considered to be a rare and highly-aggressive childhood brain cancer. The rare pediatric disease designation […]

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 and Drug Administration (FDA) for the treatment of Chagas disease in pediatric patients, from newly born to less than 18 years of age, weighing at least 2.5kg. Chagas disease is an infectious tropical disease caused by Trypanosoma […]

Continue reading …
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 and Drug Administration (FDA) for the treatment of Waldenström macroglobulinemia (WM). The orally administered Bcl-2 selective inhibitor that has been designed for the treatment of a range of hematologic malignancies by selectively inhibiting Bcl-2 to restore the […]

Continue reading …
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 of a phase 2 clinical trial. According to Center Laboratories, the orally administered small molecule drug candidate delivered significant reductions in glycated hemoglobin (HbA1c) in comparison to the placebo group. The phase 2 clinical trial is a […]

Continue reading …
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 (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options. According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications […]

Continue reading …
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 Drug Administration (FDA) to move ahead with a phase 2 clinical trial for investigating the efficacy of autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) in the prevention of Covid-19. In this connection, the Texas-based biotech company had […]

Continue reading …
Masimo gets FDA clearance for Centroid patient monitoring sensor

Masimo, a US medical device company, has received clearance from the US Food and Drug Administration (FDA) for Centroid, the company’s wearable, wireless patient orientation, activity, and respiration rate sensor. Centroid is said to aid clinicians in monitoring patient position to avoid preventable pressure ulcers. Besides, it can alert clinicians to sudden movements like fall-like […]

Continue reading …
Zogenix bags Fintepla FDA approval for Dravet syndrome treatment

Fintepla FDA approval : Zogenix has bagged approval from the US Food and Drug Administration (FDA) for Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients aged two years of age and older. Considered to be a life-threatening, rare and chronic type of epilepsy, Dravet syndrome is usually […]

Continue reading …
Reneo Pharmaceuticals gets FDA ODD for REN001 in primary mitochondrial myopathies

Reneo Pharmaceuticals has been granted the orphan drug designation (ODD) for its lead drug candidate REN001 from the US Food and Drug Administration (FDA) for the treatment of primary mitochondrial myopathies (PMM). According to the California-based clinical-stage company, REN001 is a selective PPAR delta agonist, which is being developed for the treatment of genetic myopathies, […]

Continue reading …
Roche gets FDA nod for cobas EZH2 Mutation Test as companion diagnostic for follicular lymphoma patients

Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK (tazemetostat), developed by Epizyme. According to the Swiss healthare company, the molecular test can detect abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients having follicular lymphoma […]

Continue reading …
Page 1 of 12123Next ›Last »