FDA sets PDUFA date for Anaphylm NDA resubmission
Cleared for final review, Aquestive Therapeutics received a March 16, 2027, FDA decision date for Anaphylm. The drug aims to be the first oral rescue medication for severe allergic…
SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.
Cleared for final review, Aquestive Therapeutics received a March 16, 2027, FDA decision date for Anaphylm. The drug aims to be the first oral rescue medication for severe allergic…
Sempreon, Inc. filed an amended and restated articles of incorporation to authorize stock structure. This regulatory filing details the authority for the issuance of common and pre…
Krystal Biotech reported that KB113 demonstrated over 80% regression of basal cell carcinomas in patients with Gorlin syndrome, showing a systemic immune response. This positive tr…
ImmunityBio announced an FDA expansion of the ANKTIVA plus BCG indication to include patients with BCG-unresponsive cystitis or papillary-only tumors. Market relevance: Expands com…
Rezolute has fully enrolled its Phase 3 upLIFT study for tumor hyperinsulinism, with topline data expected in mid-December. The open-label trial targets a response rate of at least…
The U.S. Food and Drug Administration announces a new Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare conditions.
Netcapital announced it regained compliance with the Nasdaq minimum bid price requirement following a 10-day closing price of over $1.00. Additionally, the company engaged Adeptus …
The Company filed an Amended and Restated Certificate of Incorporation, including a provision to eliminate related party transactions between the Company and its directors.
The FDA has approved the first therapy for bladder cancer patients unresponsive to BCG treatment. This regulatory action marks a significant milestone in oncology care.
SLM Student Loan Trust 2004-5 updated its statistical disclosure date to August 31, 2026, and outlined strict criteria for servicing the trust's collateral, including loan delinque…
StageWise Strategies Corp. amended its Articles of Incorporation to change its corporate name to TEG Overseas, Inc., increasing authorized share capital to 850 million shares, and …
5 abstracts presented at the iMRI Symposium reinforce the real-world effectiveness and clinical differentiation of the TULSA Procedure and explore platform expansion, likely suppor…
Entrada Therapeutics announces Cohort 1 of the ELEVATE-45-201 study met primary objectives with favorable safety and a statistically significant mean increase in dystrophin product…
Brightline Interactive received Nasdaq confirmation regarding compliance with the $1.00 bid price rule following a 1-for-8 reverse stock split. The recovery closes an outstanding l…
Quoin Pharmaceutical’s QRX003 has been granted Orphan Drug Designation in Europe for the treatment of Peeling Skin Syndrome, providing market exclusivity and supporting the initiat…
Trafalgar International, Inc. filed an Amended and Restated Articles of Incorporation to restate and supersede its Charter, effective upon filing with the Florida Department of Sta…
Minutes from August 17, September 9, and September 16, 2026 Board discount rate meetings are released.
Nephros, Inc. announced the date of its 2026 annual meeting to be held November 25, 2026, setting the deadline for stockholder proposals. The announcement is relevant to stakeholde…
Supa Consolidated Inc.'s auditor, LAO Professionals, has reviewed and agreed with the company's statements found within its recent Form 8-K filing.
Picard Medical filed an exhibit amending and restating its bylaws and filing this document via the SEC.