Ragothaman Srinivasan - Spark Newswire

1 minute read

Ascendis Seeks FDA Nod For TransCon PTH In Adults With Hypoparathyroidism

Today, 7:08 PM

Ascendis Pharma (NASDAQ: ASND) has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon PTH, an investigational pro-drug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism.

ASND

1 minute read

BioCryst Secures FDA Orphan Drug Status For Rare Connective Tissue Disease Candidate

By Ragothaman Srinivasan

Today, 7:08 PM

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BioCryst’s (NASDAQ: BCRX) lead asset BCX9250 for the treatment of fibrodysplasia ossificans progressiva (FOP).

BCRX

4 minute read

Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 7:08 PM

Amgen (NASDAQ:AMGN) announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib)…

AMGN

1 minute read

Amgen Shares Climb As Late-Stage Lung Cancer Study Meets Primary Endpoint

By Ragothaman Srinivasan

Today, 7:08 PM

Amgen (NASDAQ: AMGN) has announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC).

AMGN

1 minute read

Y-mAbs Gets Regulatory Approval In Israel For Neuroblastoma Candidate

By Ragothaman Srinivasan

Today, 7:08 PM

The Israeli Ministry of Health has approved Y-mAbs Therapeutics’ (NASDAQ: YMAB) lead drug DANYELZA in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.

TAK

1 minute read

Jaguar Health Seeks FDA Nod For Cholera Candidate Study

By Ragothaman Srinivasan

Today, 7:08 PM

Jaguar Health (NASDAQ: JAGX) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its subsidiary Napo's NP-300 drug product candidate for the symptomatic relief of diarrhea from cholera.

JAGX

3 minute read

Recap Of Friday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 7:08 PM

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ:INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor…

BCRX

1 minute read

Novavax Obtains U.K. Regulatory Clearance For Nuvaxovid In Adolescents Aged 12-17 Years

By Ragothaman Srinivasan

Today, 7:08 PM

The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has granted expanded conditional marketing authorization (CMA) for Novavax’s (NASDAQ: NVAX) lead asset Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caus

NVAX

1 minute read

Incyte Gets FDA Nod For Hematologic Malignancies Candidate

By Ragothaman Srinivasan

Today, 7:08 PM

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ: INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

INCY

1 minute read

Inhibikase Shares Shoot Higher As FDA Announced Clearance To Blood-Cell Cancer Study

By Ragothaman Srinivasan

Today, 7:08 PM

The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics’ (NASDAQ: IKT) Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro in the treatment of Chronic Myelogenous Leukemia (CML).

IKT