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Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update
SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its financial results for the second quarter ended June 30, 2026, and provided a business…
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ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis
SHANGHAI, Aug. 13, 2026 /PRNewswire/ — Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”) today announced that the Investigational New Drug (IND) application for AK0406 injection, the company’s first long-acting antiviral drug‑Fc conjugate (AFC) candidate for influenza prophylaxis, has been approved by the National Medical Products Administration (NMPA) of China, making AK0406 the first influenza AFC drug…
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ArkBio Completes all Cohort Dosing in Australian Phase I Trial with Influenza AFC Drug AK0406
SHANGHAI, July 24, 2026 /PRNewswire/ — Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”) today announced that all cohorts of healthy volunteers have been dosed in an Australian Phase I trial with AK0406, a novel long-acting antiviral-Fc conjugate (AFC) drug for influenza prophylaxis. The clinical trial has now entered the follow‑up phase. AK0406 is a novel long-acting…
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VERAXA Biotech Announces Regulatory Progress with its BiTAC®-TCE Development Plan
ZURICH, SWITZERLAND – July 20, 2026 – VERAXA Biotech AG (NASDAQ: VRXA; “VERAXA), an emerging leader in designing novel cancer therapies, today announced that it has received Scientific Advice from the German regulatory authority, the Paul-Ehrlich-Institute (PEI), regarding the underlying biology and proposed non-clinical development plan for its most-advanced development program based on its proprietary…
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Appili Therapeutics Announces Receipt from NIAID of a Notice of Termination for Convenience on the Contract for the VXV-01 Program
HALIFAX, Nova Scotia, July 03, 2026 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases today announced that it has received a Notice of Termination for Convenience from the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the…
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STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication
SEOUL, South Korea, July 1, 2026 /PRNewswire/ — STARMED, a medical device company specialising in minimally invasive treatment technologies, has announced that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for a thyroid-specific indication (510(k) number: K252833). The clearance took effect on 26 May 2026. The company’s system may now…
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Jelly Force Male Enhancement Gummies Release Latest Formula for Men: JellyForce Unique Ingredient Profile Report
Pinellas Park, FL, July 02, 2026 (GLOBE NEWSWIRE) — These statements have not been evaluated by the Food and Drug Administration. JellyForce is not intended to diagnose, treat, cure, or prevent any disease. Consult a qualified healthcare professional before use, especially if currently taking prescription medications. JellyForce is a gummy dietary supplement formulated for men,…
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Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs
June 30, 2026 20:38 ET | Source: Mesoblast Limited NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a…
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Appili Therapeutics Reports Fiscal Year 2026 Financial and Operational Results
LIKMEZ® (ATI-1501) commercial momentum building in U.S. market US$40 million NIAID award supporting VXV-01 advancement through Phase 1 HALIFAX, Nova Scotia, June 26, 2026 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and…
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JellyFil Publishes Updated 2026 Product Information for Its Premium Gummy Dietary Supplement, Including Full Ingredient List, Pricing, Refund Policy, and Customer Service Details
Largo, FL, June 20, 2026 (GLOBE NEWSWIRE) — These statements have not been evaluated by the U.S. Food and Drug Administration. JellyFil is not intended to diagnose, treat, cure, or prevent any disease. Consumers should consult a qualified healthcare professional before using any dietary supplement, particularly if currently taking prescription medications or managing existing health…
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BreathEaseX Publishes Updated 2026 Product Information for Its Oral Spray Dietary Supplement, Including Full Ingredient List, Pricing, Refund Policy, and Customer Service Details
AURORA, CO, June 19, 2026 (GLOBE NEWSWIRE) — These statements have not been evaluated by the U.S. Food and Drug Administration. BreathEaseX is not intended to diagnose, treat, cure, or prevent any disease. Consumers should consult a qualified healthcare professional before using any dietary supplement, particularly if currently taking prescription medications or managing existing health…
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Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470
Press Release Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470 Exclusive licensee for China, Ocumension, received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470 Based on this feedback, Ocumension intends to proceed with the New Drug Application (NDA) submission in China Submission…
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Morepen Labs' Facility Clears USFDA Inspection with NIL Adverse Observation for the Record Fourth Consecutive Time
Company sets a benchmark again in pharmaceutical excellence reinforcing its global leadership in quality and regulatory compliance Gurugram, Haryana, India Morepen Laboratories Limited (NSE: MOREPENLAB; BSE: 500288) has announced the successful completion of a USFDA (United States Food and Drug Administration) inspection at its Masulakhanna (Himachal) facility, with Zero adverse observations (No Form 483 issued…
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