BioSpace News Archive

F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses

F2G Ltd. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim, an investigational antifungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options.

June 19, 2023
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5 min read
Sun Pharma Announces Health Canada Approval of (PR)WINLEVI (clascoterone cream 1%) for Topical Treatment of Acne

WINLEVI is the first and only topical Androgen Receptor Inhibitor, and the newest Health Canada-approved formulation to target the hormonal component of acne in 40 years.

June 19, 2023
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8 min read
Biotech Bay

Galvanize Therapeutics Completes Enrollment in Pivotal Trial of RheOx® System for Chronic Bronchitis

Galvanize Therapeutics, Inc. has completed enrollment in the RheSolve pivotal trial evaluating the RheOx ® Bronchial Rheoplasty System as a treatment for chronic bronchitis symptoms.

June 19, 2023
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3 min read
Lone Star Bio

iCRYO Named the Official IV Lounge Sponsor at Upcoming IV Biz Bash Conference

iCRYO, the fast-growing recovery and wellness brand, is gearing up to serve as the official IV Lounge Sponsor at the upcoming IV Biz Bash Conference, an event designed to help entrepreneurs nationwide learn everything that it takes to start an IV business.

June 19, 2023
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2 min read
Biotech Beach

The American Diabetes Association Commences its 83rd Scientific Sessions to Showcase Game Changing Diabetes Advances

Diabetes is among the top ten leading causes of death in the United States, with more than 1.4 million new cases diagnosed each year.

June 19, 2023
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6 min read
Genetown

New Tests Yield Actionable Insights

Quest collaborated with Coriell Life Sciences to offer select medical plan members pharmacogenomics testing services indicating how specific genes and their variations impact a person’s response to medications.

June 19, 2023
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2 min read
Business

AWAK Technologies and Singapore General Hospital launch pre-pivotal clinical trial of wearable peritoneal dialysis device

AWAK Technologies (AWAK) and Singapore General Hospital (SGH) announce the launch of a pre-pivotal clinical trial with the enrolment of their first subject to study the safety and efficacy of an improved Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.

June 19, 2023
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5 min read
Drug Development

Sensorion Reports Promising Preliminary Data from SENS-401 Phase 2a Clinical Study

Sensorion announces promising preliminary results from its Proof of Concept Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation.

June 19, 2023
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7 min read
Genetown

Biophytis Reports Clinical Results for Sarconeos (BIO101) in Sarcopenia Treatment at the 16th SCWD International Congress

Biophytis SA announces that it is taking part in the 16th SCWD international congress, a flagship event bringing together experts from all over the world to share thoughts, research and innovations on sarcopenia, cachexia and wasting disorders.

June 19, 2023
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4 min read
Business

Beactica Therapeutics appoints Jarl Ulf Jungnelius M.D. to its Board of Directors as it advances towards clinical-stage activities

Beactica Therapeutics AB, the Swedish precision oncology company, announced the appointment of Jarl Ulf Jungnelius M.D. to its Board of Directors.

June 19, 2023
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2 min read