# FDA Type: Company Source: GetYourBrief — https://getyourbrief.com/entity/fda Canonical HTML page: https://getyourbrief.com/entity/fda ## Timeline - **2026-09-14**: $385 million settlement announced — Abbott agrees to pay $385 million to resolve Justice Department claims and lawsuits by relators and state Attorneys General; Abbott says the deal is not a finding of fault or liability. - **2026-09-11**: Updated vaccines available — Updated COVID-19 and flu vaccines become available in the Bay Area. - **2026-09-06**: Coverage Highlights Market Divergence — Financial media report on the stock's surge and note some Wall Street price targets are more upbeat than Cramer's caution. - **2026-09-06**: Coverage Highlights Market Divergence — Financial media report on the stock's surge and note some Wall Street price targets are more upbeat than Cramer's caution. - **2026-09-03**: Cramer Calls NUVB 'Pure Speculation' — On CNBC's Mad Money, Jim Cramer warns Nuvation Bio trades on what pipeline drugs might do someday rather than steady revenue. - **2026-09-03**: Cramer Calls NUVB 'Pure Speculation' — On CNBC's Mad Money, Jim Cramer warns Nuvation Bio trades on what pipeline drugs might do someday rather than steady revenue. - **2026-08**: FDA Grants Fast Track Designation to Safusidenib — Nuvation Bio's experimental brain cancer drug safusidenib receives FDA Fast Track status for IDH1-mutant glioma. - **2026-08**: FDA Grants Fast Track Designation to Safusidenib — Nuvation Bio's experimental brain cancer drug safusidenib receives FDA Fast Track status for IDH1-mutant glioma. - **2026-08**: Bay Area positivity hits 9% — State data show positive COVID-19 tests at moderate levels, slightly more than 9%. - **2026**: Nationwide Cyclospora outbreak tied to contaminated lettuce — An ongoing nationwide Cyclospora outbreak is linked to contaminated lettuce and a Mexican farm, drawing attention to the declining FDA foreign inspection capacity. - **2025**: Major SARS-CoV-2 variation emerges — A major viral variation emerges and is later named XFG or Stratus. - **2025**: Trump administration relaxes COVID-19 vaccine recommendations — Federal recommendations are relaxed, creating widespread confusion in the Bay Area. - **2022-06**: Sturgis plant reopens — Abbott reopens the largest U.S. baby formula plant by June 2022 after the shutdown. - **2022-02**: Sturgis plant closure and recall — Abbott closes the Sturgis, Michigan facility after the FDA begins an investigation; recall covers powdered infant formula brands including Similac. - **2022**: Federal emergency response — The Biden administration eases import rules, airlifts formula from Europe, and invokes federal emergency rules to prioritize U.S. production during the formula shortage. ## Recent coverage (8 stories, network-wide) ### Abbott's $385M Formula Plant Deal Resolves DOJ and Qui Tam Claims 2026-09-14 21:50:39 · Sector: legal · Sentiment: Negative · Impact: 7/10 · Sources: 2 Abbott will pay $385M to resolve DOJ, relator, and state AG claims tied to the Sturgis formula shutdown while denying liability. The case shows how a single plant failure can create multi-front federal, qui tam, and state exposure. Full story: https://getlegalbrief.com/story/abbott-385m-formula-plant-settlement-legal-exposure ### Bay Area COVID positivity hits 9% as updated vaccines roll out 2026-09-13 22:07:12 · Sector: health · Sentiment: Neutral · Impact: 5/10 · Sources: 2 Updated COVID-19 and flu vaccines are now available across the Bay Area just as positive tests exceed 9%. Healthcare leaders need clear eligibility guidance and operational readiness for the 2026-27 respiratory season. Full story: https://gethealthbrief.com/story/bay-area-covid-positivity-9-updated-vaccines ### FDA Clears 3 Updated COVID Shots as XFG/Stratus Dominates 2026-09-13 22:06:56 · Sector: bio · Sentiment: Neutral · Impact: 5/10 · Sources: 2 The FDA has cleared updated COVID-19 vaccines from Pfizer, Moderna, and Novavax for 2026-27, targeting the XFG/Stratus strain. The decision resets the competitive landscape for seasonal vaccine makers. Full story: https://getbiobrief.com/story/fda-clears-3-covid-shots-xfg-stratus ### Cyclospora Outbreak Exposes 35% FDA Inspection Decline: Health Risk 2026-09-08 19:59:23 · Sector: health · Sentiment: Negative · Impact: 6/10 · Sources: 2 A nationwide Cyclospora outbreak tied to contaminated lettuce highlights a 35% drop in FDA foreign food inspections since 2019, raising concerns about foodborne illness surveillance and prevention. Full story: https://gethealthbrief.com/story/cyclospora-outbreak-fda-inspection-decline-public-health ### 35% Drop in FDA Foreign Inspections Threatens Fresh Produce Supply 2026-09-08 19:57:43 · Sector: supply · Sentiment: Negative · Impact: 6/10 · Sources: 2 With FDA foreign food inspections down nearly 35% since 2019, contaminated lettuce linked to a Mexican farm triggered a nationwide Cyclospora outbreak—forcing importers and retailers to reassess supplier audits and traceability. Full story: https://getsupplybrief.com/story/fda-inspection-decline-produce-supply-chain ### FDA Foreign Inspections Drop 35% Since 2019, Raising Legal Exposure 2026-09-08 19:56:31 · Sector: legal · Sentiment: Negative · Impact: 6/10 · Sources: 2 AP investigation finds FDA foreign food inspections dropped nearly 35% since 2019 as a Cyclospora outbreak tied to Mexican lettuce raises food safety compliance obligations. Counsel should anticipate increased enforcement, recalls, and civil liability across import supply chains. Full story: https://getlegalbrief.com/story/fda-foreign-inspections-legal-liability ### Cramer's 5-Word NUVB Warning as Biotech Surges: 2026 Net Loss Expected 2026-09-07 19:39:28 · Sector: finance · Sentiment: Neutral · Impact: 5/10 · Sources: 2 Jim Cramer's September 3 'pure speculation' call on Nuvation Bio hits at a moment of momentum: shares rose on FDA Fast Track news and strong early IBTROZI adoption. Yet analysts forecast a full-year 2026 net loss, making the rally a contest between pipeline optionality and burn rate. Full story: https://getfinancebrief.com/story/nuvation-bio-cramer-pure-spec-net-loss-valuation ### Nuvation Bio's 1 Approved Drug vs Cramer's 5-Word 'Pure Spec' Call 2026-09-07 19:39:18 · Sector: bio · Sentiment: Neutral · Impact: 5/10 · Sources: 2 Nuvation Bio's experimental brain cancer drug safusidenib won FDA Fast Track in August 2026, but Jim Cramer on CNBC called the surging stock pure speculation. While IBTROZI showed commercial traction as the most-prescribed new lung cancer treatment in early 2026, most value still hinges on late-stage pipeline data. Full story: https://getbiobrief.com/story/nuvation-bio-cramer-pure-spec-fast-track-safusidenib --- This page is a machine-readable summary. Sentiment measures the directional read of each development for this entity, not the tone of the reporting; impact weights consequence, not syndication reach. 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