United States — Food and Drug Administration & KC Pharmaceuticals
9 shared events · Importance 5 · Last updated Jul 30, 2026
Live sentiment trends, interaction importance charts, and action volume tracking available on the
Ergen Dashboard
Regulatory
United States — Food and Drug Administration: Regulatory body that classified the recall; performing its oversight role.
KC Pharmaceuticals: Initiator of the recall; faces potential reputational damage and financial liability.
Jul 24, 2026 · 12 articles
Business
United States — Food and Drug Administration: The FDA is reviewing PolyPid's NDA for D-PLEX100, with acceptance expected in August 2026. The agency previously granted Breakthrough Therapy Designation for the product.
KC Pharmaceuticals: Azurity gains exclusive commercialization rights to D-PLEX100 in the U.S. and Canada, expanding its specialty pharmaceutical portfolio. It will fund clinical development for label expansion, positioning for future revenue.
Jul 21, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The FDA published the recall announcement and is monitoring the situation, fulfilling its regulatory oversight role.
KC Pharmaceuticals: As the parent company of Unique Pharmaceutical Laboratories, KC Pharmaceuticals faces potential reputational damage and scrutiny over manufacturing quality control.
Jul 21, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: Regulatory body that classified the recall; its oversight role is central to the event.
KC Pharmaceuticals: Mentioned as a prior recaller; context for industry-wide sterility issues.
Aug 20, 2026 · 6 articles
Business
United States — Food and Drug Administration: The Taiwan FDA granted marketing approval for QUVIVIQ, a regulatory milestone that enables commercialization in Taiwan.
KC Pharmaceuticals: Centessa was acquired by Eli Lilly, completing a transaction that validates the value of its orexin receptor agonist programs. Nxera retains rights to future payments from these programs.
Aug 07, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA is mentioned as the agency that could grant orphan-drug designation for S-100 and evaluate eligibility for the Rare Pediatric Disease Priority Review Voucher Program. This is a potential future regulatory pathway.
KC Pharmaceuticals: KC Pharmaceuticals, 64% owned by Lobe, is mentioned as a subsidiary developing L-130 for neurological disorders. The private placement is not directly allocated to Cynaptec, but the company benefits from Lobe's overall financial health.
Aug 12, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The FDA classified the recall as Class II and issued public notices, reinforcing its regulatory oversight role.
KC Pharmaceuticals: KC Pharmaceuticals was involved in a prior unrelated eye drop recall; mentioned for context but not directly affected.
Jul 07, 2026 · 38 articles
Business
United States — Food and Drug Administration: The FDA declined to approve Lantheus' LNTH-2501 application due to manufacturing issues, a setback for Lantheus' pipeline.
KC Pharmaceuticals: KC Pharmaceuticals was acquired by AstraZeneca, serving as a comparable deal in the radiopharmaceutical sector.
Aug 03, 2026 · 7 articles
Business
United States — Food and Drug Administration: The FDA granted Breakthrough Therapy Designation to BPL-003 and announced regulatory actions to support psychedelic drug development, facilitating the path to market.
KC Pharmaceuticals: KC Pharmaceuticals was acquired by AbbVie in 2024 for an experimental psychedelic depression therapy, illustrating the competitive landscape.
Jul 16, 2026 · 25 articles
ERGEN INTELLIGENCE
Explore this relationship live
Track how United States — Food and Drug Administration and KC Pharmaceuticals interact across events, view sentiment trends, and discover connected entities.
Open Dashboard