BioSpace News Archive

Business

Elite Pharmaceuticals, Inc. Reports Financial Results for the Fiscal Year Ended March 31, 2023 and Provides Conference Call Information

Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, announced results for the fiscal year ended March 31, 2023 (“Fiscal 2023").

June 29, 2023
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3 min read
Policy

FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease

Renalytix plc announces that the U.S. Food and Drug Administration has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test.

June 29, 2023
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6 min read
Policy

AVITA Medical Submits FDA PMA Supplement for RECELL GO

AVITA Medical, Inc. announced its submission of a premarket approval supplement to the U.S. Food and Drug Administration for RECELL GO™.

June 29, 2023
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4 min read
Policy

FDA Approves First Gene Therapy for Adults with Severe Hemophilia A

The U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

June 29, 2023
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4 min read
Drug Development

SK bioscience-Sanofi Announce Positive Results from Phase II Study of 21-Valent Pneumococcal Conjugate Vaccine Candidate

SK bioscience announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, ‘GBP410', evaluating its safety and immunogenicity.

June 29, 2023
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4 min read
Deals

Intensity Therapeutics, Inc. Announces Pricing of Upsized Initial Public Offering, Raising Approximately $19.5 Million in Gross Proceeds

Intensity Therapeutics, Inc. announced the pricing of its upsized initial public offering of 3,900,000 shares of common stock at a public offering price of $5.00 per share.

June 29, 2023
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4 min read
FDA

FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy

ARUP Laboratories announced that the U.S. Food and Drug Administration has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™.

June 29, 2023
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5 min read
Genetown

Black Diamond Therapeutics Announces Pricing of Public Offering of Common Stock

Black Diamond Therapeutics, Inc. announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $5.00 per share.

June 29, 2023
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4 min read
Business

MedMira Reports Third Quarter Results FY2023

MedMira Inc., reported on its financial results for the quarter ended April 30, 2023.

June 29, 2023
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3 min read
Bioheart (02185.HK) announces clinical result for Iberis-HTN at CIT 2023

Bioheart, together with its holding subsidiary Angiocare announces the clinical result for Iberis-HTN at China Interventional Therapeutics 2023.

June 29, 2023
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2 min read