Biotech Archives - Page 680 of 733

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

August 26, 11:42 AM

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

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Incyte Gets FDA Nod For Hematologic Malignancies Candidate

By Ragothaman Srinivasan

August 26, 10:47 AM

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

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Pfizer And BioNTech Complete Submission to European Medicines Agency For Omicron BA.4/BA.5 Adapted Bivalent Vaccine

By Benzinga Newsdesk

August 26, 9:45 AM

Submission follows application for Omicron BA.1-adapted bivalent vaccine submitted in July If authorized, both Omicron BA.1-adapted and Omicron BA.4/5-adapted bivalent vaccines will be available in the European

BNTX

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Moderna Entangles Pfizer/BioNTech In COVID-19 Vaccine Patent Lawsuits: All You Need To Know

By Vandana Singh

August 26, 9:24 AM

Moderna Inc (NASDAQ: MRNA) has

ABUS

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

By Ragothaman Srinivasan

August 26, 9:16 AM

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

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BioCryst Exhibits Positive Data From Early-Stage Rare Kidney Disease Study

By Ragothaman Srinivasan

August 26, 8:50 AM

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that its lead asset BCX9930 has demonstrated >99 percent suppression of the alternative pathway (AP), and that >98 percent suppression was maintained for 24 hours post-dosing, in patients with C3 glomerulopathy (C3G), a rare renal disease that is characterized by dysregulation of the AP of the complement system.

BCRX

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89bio’s Pegozafermin Data Shows Improved Liver Fat, Glycemic Control

By Vandana Singh

August 26, 8:05 AM

89bio Inc (NASDAQ:ETNB) announced the presentation of data from the ENTRIGUE Phase 2 proof-of-concept trial of pegozafermin in severe hypertriglyceridemia (SHTG)…

ETNB

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Sanofi Higher Dose Flu Vaccines Preferentially Recommended For Adults 65+ In CDC Morbidity And Mortality Weekly Report

By Benzinga Newsdesk

August 26, 8:04 AM

This recommendation may help reduce the risk of the flu and flu-related complications in this high-risk population Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and

SNY