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Top 6 fda News Today

#1
Cadrenal Therapeutics advances CAD-1005 to pivotal Phase 3 after FDA End-of-Phase 2 meeting
#1 out of 6
health1d ago

Cadrenal Therapeutics advances CAD-1005 to pivotal Phase 3 after FDA End-of-Phase 2 meeting

https://www.tradingview.com/news/tradingview:35d0b50cbe27b:0-cadrenal-therapeutics-advances-cad-1005-to-pivotal-phase-3-after-fda-end-of-phase-2-meeting/
Tradingview.com
  • Cadrenal moves CAD-1005 to a pivotal Phase 3 trial after an FDA End-of-Phase 2 meeting.
  • The pivotal trial will enroll about 120 patients across up to 50 centers worldwide.
  • Primary endpoint centers on centrally adjudicated thrombotic events in SRA-confirmed HIT.
  • FDA guidance covered protocol design, population, dosing, background therapy, and safety database.
  • CAD-1005 added to standard anticoagulant therapy showed over a 25% absolute reduction in thrombotic events in Phase 2.
  • The trial plans to enroll HIT patients receiving standard-of-care anticoagulation.
  • The Phase 3 will be blinded and placebo-controlled, with randomized design.
  • Interim analysis is planned as part of the Phase 3 protocol.
  • A potential NDA submission is targeted for 2029.
  • The update confirms expansion plans across multiple centers worldwide.
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#2
Telomir Pharmaceuticals gets FDA IND clearance for Telomir-Zn, Phase 1/2 trial planned for 1H 2026
#2 out of 6
health1d ago

Telomir Pharmaceuticals gets FDA IND clearance for Telomir-Zn, Phase 1/2 trial planned for 1H 2026

https://www.tradingview.com/news/tradingview:c802b9c08d36b:0-telomir-pharmaceuticals-gets-fda-ind-clearance-for-telomir-zn-phase-1-2-trial-planned-for-1h-2026/
Tradingview.com
  • FDA clears Telomir-Zn IND, enabling a Phase 1/2 trial for advanced TNBC in 1H 2026.
  • The Phase 1/2 study will enroll about 76 patients with dose-escalation and expansion.
  • Phase 1 will assess safety, MTD, recommended Phase 2 dose, PK/PD, and biomarker work.
  • Phase 2 will evaluate efficacy with ORR as the primary endpoint and other endpoints including DoR, PFS, OS, and safety.
  • The announcement references Telomir Pharmaceuticals’ SEC filing and notes the summary may contain inaccuracies.
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#3
Trump administration move to reclassify cannabis sparks confusion
#3 out of 6
politics1d ago

Trump administration move to reclassify cannabis sparks confusion

https://www.theguardian.com/us-news/2026/apr/30/trump-administration-cannabis-rescheduling-confusing
Theguardian.com
  • The Trump administration moved some cannabis products from Schedule I to Schedule III, signaling partial rescheduling.
  • Experts say the order is only a partial rescheduling and does not broadly reclassify marijuana.
  • Analysts warn the FDA-approved part applies only to future products, not existing cannabis medicines.
  • The administration cites the Single Convention on Narcotic Drugs to justify the move but leaves questions about implementation.
  • Industry executives say the change creates confusion about whether medical and adult-use cannabis are treated differently.
  • Experts expect potential regulatory signals for medical cannabis patients, though practical protections remain uncertain.
  • DEA will hold a new administrative hearing on rescheduling on June 29, with full rescheduling still uncertain.
  • Commentary suggests the policy may appeal to some voters but not resolve broader legalization support.
  • Some see the move as a signal of federal openness to medical cannabis despite ongoing state- and industry-level debates.
  • The policy emphasizes medical cannabis recognition but faces implementation and equity concerns for minority entrepreneurs.
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#4
Key facts: Panel Rejects AZ Breast Drug; FDA Approves Saphnelo
#4 out of 6
health13h ago

Key facts: Panel Rejects AZ Breast Drug; FDA Approves Saphnelo

https://www.tradingview.com/news/tradingview:4025e497234dd:0-key-facts-panel-rejects-az-breast-drug-fda-approves-saphnelo/
Tradingview.com
  • An FDA advisory panel voted against AstraZeneca’s breast cancer drug, citing an unfavorable risk–benefit profile.
  • The FDA approved AstraZeneca’s Saphnelo autoinjector for once-weekly self-injection in adults with SLE.
  • The approval follows Phase III TULIP-SC results and signals AstraZeneca’s broader regulatory activity.
  • TradingView notes ongoing royalty terms to Bristol-Myers Squibb in relation to Saphnelo.
  • The report places these regulatory actions within AstraZeneca’s broader portfolio and regulatory context.
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#5
Thinking about peptides? Doctors reveal key dos and don’ts as ‘Wild West’ market grows
#5 out of 6100.00%
health3h ago

Thinking about peptides? Doctors reveal key dos and don’ts as ‘Wild West’ market grows

https://www.foxnews.com/health/thinking-peptides-doctors-reveal-key-dos-donts-wild-west-market-grows
Foxnews.com
  • Regulators weigh easing peptide rules, labeling the market as a 'Wild West' amid online sales and varied oversight.
  • Experts warn that peptides are powerful but can be dangerous if sourced improperly or misused.
  • Physicians advise consulting clinicians and using reputable pharmacies with proper prescription.
  • Experts emphasize biomarker testing before starting peptides to establish a baseline.
  • Peptides should be used as part of a broader health plan rather than a quick fix.
  • Younger individuals may not need peptides for muscle building according to a fitness expert.
  • Peptides should be cycled and reassessed rather than used continuously.
  • Regulatory voices stress the need for FDA-reviewed products and qualified pharmacies.
  • Participants are urged to use reputable compounding pharmacies and prescription oversight.
  • The article notes the market's growth as wellness influencers popularize peptide use.
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#6
Trump is sold on psychedelic therapy. What does the science say?
#6 out of 6
politics2h ago

Trump is sold on psychedelic therapy. What does the science say?

https://www.scientificamerican.com/podcast/episode/trump-ibogaine-and-the-science-behind-the-psychedelics-boom-in-the-u-s/
Scientificamerican.com
  • The administration issued an executive order to accelerate psychedelic research and potential drug approvals in the United States.
  • The order includes a voucher program to speed FDA review of psychedelic therapies.
  • Funding set aside could help ibogaine research through state partnerships, notably Texas.
  • Texas has already pledged $50 million for ibogaine research, aligned with the order.
  • Experts warn the White House push should not compel FDA outcomes, which should remain independent.
  • Ibogaine’s resurgence is tied to veteran health concerns and advocacy for U.S. access.
  • RFK Jr. has been identified as a key figure among psychedelic advocates backing the administration's move.
  • There is ongoing debate about therapy versus psychedelic drugs in treatment outcomes.
  • Public interest centers on ibogaine for substance-use and veteran health, amid broader psychedelics revival.
  • Experts caution that ibogaine carries heart risks and a lengthy, intense experience.
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