BioCardia files revised Helix De Novo submission to FDA
BioCardia completed a revised pre-submission for its Helix Catheter based on FDA guidance, aiming for approval as a unique therapeutic delivery device. This clearance could signifi…
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BioCardia completed a revised pre-submission for its Helix Catheter based on FDA guidance, aiming for approval as a unique therapeutic delivery device. This clearance could signifi…
Japan's MHLW approved Novocure's Optune Pax for unresectable, locally advanced pancreatic cancer, delivering a significant milestone for the company's therapy platform.
BNB Plus Corp. amended its Registration Rights Agreement to replace mandated registration with demand-only rights and withdrew its S-1 registration statement filed in August 2026. …
Orchestra BioMed has surpassed its target of 316 patients in the pivotal BACKBEAT trial. Full enrollment positions the company to submit primary endpoint data in late 2027, support…
Azitra announced the completion of Cohort 1 and clearance for Cohort 2 of a clinical trial evaluating drug candidate ATR04-484 as a treatment for EGFR inhibitor-induced skin rash, …
Allarity received recent patent awards and CLIA certification to retain exclusive control of its Drug Response Predictor test for stenoparib, aiding its clinical development strate…
Nektar Therapeutics announced long-term data for rezpegaldesleukin at EADV 2026, showing durable hair regrowth after treatment cessation and initiation of Phase 3 studies.
Monte Rosa Therapeutics reported degrader MRT-8102 normalized key ASCVD drivers in obese subjects with high CVD risk, revealing a favorable safety profile and opening pathways for …
NN, Inc. filed an Amended and Restated Certificate of Incorporation with the Delaware Secretary of State, updating its authorized capital stock structure and corporate governance d…
Cuentas Inc. has ammended and restated its warrant agency agreement with Olde Monmouth Stock Transfer Co., Inc., further modifying the terms of its outstanding warrants.
Goldman Sachs Private Middle Market Credit II LLC and its lenders have entered into a First Amendment to their loan and security agreement, amending terms outlined in the new execu…
Tevogen Inc. received official notice resolving both Nasdaq noncompliance issues on September 29, 2026, ensuring continued listing on the Global Market.
Aeluma, Inc. filed an 8-K amending and restating its bylaws, effective September 29, 2026. The changes detail shareholder meeting procedures, director powers, and corporate governa…
FDA Launches Nationwide Effort for Advisory Committee Candidates to Expand Expertise and Perspectives on Public Health Decisions.
The Federal Reserve has finalized modifications to its stress tests to enhance transparency and accountability while decreasing volatility in capital requirements.
DigitalBridge Group filed an 8-K to amend and restate its charter. The filing details the company's secondary organizational structure and governance provisions.
Celcuity Inc. announced that REVTORPYK (gedatolisib), an FDA-approved breast cancer therapy, is commercially available in the US. The launch follows recent regulatory approvals and…
AEON Biopharma received FDA encouragement for a streamlined development path for ABP-450, supporting a potentially more efficient clinical program and indicating no immediate need …
Rafael Holdings disclosed that Trappsol Cyclo failed its primary endpoint in a pivotal NPC study despite positive prespecified subgroup results, resulting in a potential delay to t…
Professional Diversity Network has regained compliance with Nasdaq's minimum bid price requirement following a reverse stock split. This resolves the delisting concern related to i…