Brazil & United States — Food and Drug Administration
9 shared events · Importance 3 · Last updated Jun 03, 2026
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Business
Brazil: Brazil is identified as a global market where FDA approval could accelerate regulatory pathways for Jyong Biotech's products.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) approval is a critical milestone for Jyong Biotech's lead drug candidates, as it enables market access and sets a precedent for global regulatory pathways.
May 29, 2026 · 7 articles
Accidents
Brazil: Brazil>>> is investigating suspected Ebola cases tied to travel from affected African nations. While initial tests for other diseases were positive, the possibility of Ebola has not been ruled out, creating uncertainty and potential for wider spread.
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.
May 18, 2026 · 505 articles
Business
Brazil: Sun Pharma received semaglutide approval in Brazil, underscoring its capabilities in complex peptide products and expanding its global footprint.
United States — Food and Drug Administration: Sun Pharma filed three ANDAs and received approvals for six during the quarter, with 119 ANDAs awaiting FDA approval, reflecting ongoing regulatory engagement.
Jul 31, 2026 · 7 articles
Regulatory
Brazil: Brazil is the target country for the vaccine, bearing a high chikungunya burden; approval could reduce disease impact and healthcare costs.
United States — Food and Drug Administration: Previously approved the vaccine; not directly involved in this submission.
Jul 13, 2026 · 6 articles
Business
Brazil: Brazil's ANVISA accreditation is one of the regulatory approvals held by the company, supporting its market access.
United States — Food and Drug Administration: The USFDA accreditation is a key regulatory approval for the company, enabling access to the US market.
Aug 03, 2026 · 6 articles
Domestic
Brazil: Also recommends 18 vaccines, further contradicting the administration's comparison.
United States — Food and Drug Administration: Responsible for approving any new separate vaccines, a process that could take years. It faces pressure to review unbundled shots without precedent.
Aug 10, 2026 · 235 articles
Regulatory
Brazil: Brazil faced separate US tariffs (25%) on some products, but is not directly affected by the generic drug tariff.
United States — Food and Drug Administration: The FDA noted that generics constitute over 90% of US prescriptions, highlighting the policy's broad impact.
Jul 21, 2026 · 73 articles
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