#fda
Latest news and interesting information about fda.
ImmunityBio secures exclusive U.S. rights to Tokyo BCG strain
ImmunityBio secures exclusive U.S. rights to the Tokyo BCG strain for bladder cancer treatment. SWOG S1602 trial shows promising results.
FDA drug center head expected to leave after commissioner exit
Acting FDA drug center head Tracy Hoeg expected to leave after Commissioner Makary's resignation.
20 deaths from US drug in Japan
20 deaths reported in Japan from US-made vasculitis drug Tavneos. Kissei Pharmaceutical advises stopping use due to liver damage.
FDA drug center head fired after commissioner exit
Tracey Beth Hoeg, acting head of the FDA drug center, has been fired following Commissioner Makary's resignation amid health department changes.
Amgen stock falls on Tavneos liver risk
Amgen shares drop 2.1% as Tavneos liver risks emerge. FDA and EMA take action. Kissei reports 20 deaths in Japan.
PAVmed Q1 2026: Restructuring Gains Highlighted
PAVmed Inc. reported Q1 2026 results with restructuring gains and product development progress. Stock up 3.1%.
Caris Identifies 13,293 Patients Eligible for New Cancer Therapies
Caris Life Sciences identifies 13,293 patients eligible for new cancer therapies via Lookback Program, covering 10 tumor types.
Canaccord Reaffirms GH Research Stock Rating on Phase 3 Progress
Canaccord Genuity keeps Buy rating on GH Research stock as Phase 3 program for GH001 advances. Key financial highlights included.
BTIG Reiterates Neutral on Insight Molecular Amid FDA Review
BTIG reiterates Neutral rating on Insight Molecular Diagnostics (IMDX) as FDA reviews GraftAssureDx transplant test. Stock up 28% in a week. Revenue surges 116%.
Morgan Stanley Downgrades Aardvark Stock
Morgan Stanley downgrades Aardvark Therapeutics stock to Underweight, price target $3, after FDA clinical hold on ARD-101 over safety concerns.
US Supreme Court allows abortion pill mail delivery
The US Supreme Court allowed the abortion pill mifepristone to continue being prescribed via telemedicine and mailed, restoring a 2023 FDA rule challenged by Louisiana.
US Supreme Court Preserves Abortion Pill Access
US Supreme Court preserves access to abortion pill mifepristone via telehealth and mail. Learn about the FDA rule, ongoing lawsuits, and state responses.
Elutia Q1 2026: EPS Miss, Revenue Beat
Elutia Q1 2026 results: EPS misses estimates, revenue beats. Details on NXT-41X program and FDA timeline.
Supreme Court upholds abortion pill mail access
The Supreme Court has granted a stay allowing mifepristone to be dispensed by mail during ongoing litigation, blocking a Fifth Circuit ruling that required in-person dispensing.
Elutia reports Q1 results, expects FDA clearance for NXT-41
Elutia reports Q1 2026 financial results and expects FDA clearance for NXT-41 product in Q4 2026.
Mira stock rises on Phase 1 trial results
Mira Pharmaceuticals shares rise 5% after positive Phase 1 results for Ketamir-2. Company advances toward Phase 2a for chemotherapy-induced neuropathy.
Cingulate Reports Q1 Loss
Cingulate Q1 2026 results: net loss $9.3M, cash at $25.9M. ADHD drug candidate CTx-1301 advances with FDA.
US cancer centers rush for Revolution drug
U.S. cancer centers are rushing to enroll patients in an early access program for Revolution Medicines' promising pancreatic cancer drug.
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