FDA Archives - Page 202 of 220

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FDA
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AstraZeneca Announced Calquence Tablet Formulation Approved in the US Across Current Indications

August 5, 7:26 AM

AstraZeneca's new tablet formulation of Calquence (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL), which is approved under accelerated approval based on overall response rate.

AZN

3 minute read

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

By Ragothaman Srinivasan

August 4, 6:07 PM

ARQT

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FDA
News

Akebia Therapeutics Announces Initial Findings From Investigator-Sponsored Clinical Study Evaluating Vadadustat For Prevention And Treatment Of Acute Respiratory Distress Syndrome (ARDS) In Subjects With COVID-19 And Hypoxemia (VSTAT)

By Benzinga Newsdesk

August 4, 5:27 PM

Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced initial findings from an

AKBA

1 minute read

Marker Therapeutics Shares Jump 60 Percent As FDA Announced Clearance To Blood Cell Cancer Study

By Ragothaman Srinivasan

August 4, 5:01 PM

The U.S. Food and Drug Administration (FDA) announced clearance to Marker Therapeutics’ (NASDAQ: MRKR) Investigational New Drug (IND) application for MT-601 for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma.

MRKR

1 minute read

TELA Bio Earlier Highlighted Results From BRAVO And ReBAR Studies On The Benefits Of OviTex Reinforced Tissue Matrix In Hernia Repairs; Data To Be Presented At 2022 American Hernia Society (AHS) Meeting

By Benzinga Newsdesk

August 4, 12:32 PM

24-Month BRAVO study results showed a 2.6% recurrence rate in diverse clinical scenarios Robotic Reinforced Biologic Augmented Repair (ReBAR) study showed a 1.9% recurrence rate at two-year

TELA

2 minute read

FDA Lifts Clinical Hold On BioCryst’s BCX9930 Program For Rare Blood Disorder

By Vandana Singh

August 4, 12:11 PM

The FDA lifted a partial clinical hold on BioCryst Pharmaceuticals Inc’s (NASDAQ:BCRX) BCX9930 program. The company will resume enrollment under revised protocols…

BCRX

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FDA
News

Novavax Announces Initiation Of Phase 2b/3 Hummingbird Global Clinical Trial For Novavax COVID-19 Vaccine In Children Aged Six Months Through 11 Years

By Benzinga Newsdesk

August 4, 9:04 AM

Novavax, Inc. (NASDAQ:NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the initiation of its Phase 2b/3

NVAX

1 minute read

BioCryst Pharmaceuticals Says FDA Has Lifted Partial Clinical Hold On BCX9930 Program

By Bill Haddad

August 4, 7:58 AM

On August 4, 2022, the company announced that the U.S. Food and Drug Administration (FDA) has lifted its partial clinical hold on the BCX9930 program. The company will resume enrollment in global clinical trials under

BCRX

1 minute read

FDA Says Travere’s Sparsentan Data Not Sufficient For Accelerated Approval In One Indication

By Vandana Singh

August 4, 7:36 AM

Travere Therapeutics Inc (NASDAQ: TVTX) completed its planned FDA Type A meeting for a potential submission for accelerated approval of sparsentan for focal segmental glomerulosclerosis (FSGS), a rare disease affecting the kidney filters.

TVTX