FDA
46 stories in The Vital Record · Agency
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· Biotech Business
Parabilis Medicines Prices Record $670M Biotech IPO; Regeneron Takes $75M Concurrent Stake -
· Devices & Diagnostics
FDA Clears Medtronic's Nellcor Nell-EQ Pulse Oximeter Under New Skin-Tone Equity Standard -
· FDA & Regulatory
FDA Accepts Giredestrant NDA Under Priority Review for Early ER+ Breast Cancer — Decision Due November 30 -
· FDA & Regulatory
FDA Adds First New Sunscreen Active Ingredient in 25 Years: Bemotrizinol Cleared via CARES Act Monograph Process -
· Research
First Human Liver Biopsy Shows 54–57% On-Target Correction of SERPINA1 After In Vivo Base Editing -
· Devices & Diagnostics
BD BACTEC FXI Receives 510(k) Clearance, Detecting Sepsis Pathogens About Three Hours Faster Than Its Predecessor -
· Research
AstraZeneca's Oral GLP-1 Pill Trims 11.8% Body Weight in Phase 2 — Phase 3 Now Enrolling -
· FDA & Regulatory
VRBPAC Convenes June 18 on Moderna's MFLUSIVA — First mRNA Seasonal Influenza BLA Before an FDA Panel -
· Public Health
Clover Hill Dairy Recalls Requesón and Soft Ricotta After Listeria Kills One and Hospitalizes Eight in Three-State Outbreak -
· Biotech Business
Investigational Once-Weekly HIV Pill Meets Primary Endpoints in Both Phase 3 ISLEND Trials -
· Clinical Trials
Aficamten Beats Metoprolol on Exercise Capacity in Phase 3 Head-to-Head Trial for Obstructive HCM -
· Devices & Diagnostics
FDA clears next-gen GI Genius colonoscopy AI from Medtronic and Cosmo -
· Biotech Business
Incyte to buy Vega Therapeutics for up to $2B, betting on a subcutaneous bleeding-disorder antibody still in trials -
· FDA & Regulatory
FDA accepts a proposed Entyvio biosimilar for review; interchangeability not yet granted -
· Devices & Diagnostics
FDA Early Alert: oxygen-blender shaft in GE HealthCare Giraffe and Panda infant resuscitation systems can loosen and misdeliver oxygen -
· Clinical Trials
Intercept ends Phase 3 obeticholic acid extension trial after FDA withdraws Ocaliva approval -
· Biotech Business
GSK to buy Nuvalent for $10.6 billion, betting on two investigational lung-cancer drugs awaiting FDA decisions -
· Research
In a phase 3 trial, the GLP-1 pill orforglipron cut HbA1c about 1.1 points beyond placebo when added to titrated basal insulin -
· Biotech Business
Incyte to buy a Phase 3 bleeding-disorder antibody for $1.25B in cash -
· Devices & Diagnostics
FDA warns of Omnipod cannula tear that can quietly cut off insulin — sometimes with no alarm -
· FDA & Regulatory
FDA approves first PROTAC degrader, narrowing it to ESR1-mutated breast cancer after the overall trial missed -
· Digital Health & AI
Philips clears Elevate Plus, moving Koios breast and thyroid AI onto the ultrasound cart -
· Biotech Business
Servier to buy Edgewise's investigational dystrophy drug sevasemten for up to $2.65B as Edgewise turns to cardiology -
· Biotech Business
Otsuka files to convert VOYXACT to full approval in IgA nephropathy, citing a 5.5 mL/min interim eGFR edge at one year -
· FDA & Regulatory
FDA approves AbbVie's DECNUPAZ for ultra-rare blood cancer BPDCN, on a single-arm response endpoint -
· Research
An investigational lymphoma antibody cleared more protein than tacrolimus in a hard-to-treat kidney-disease trial -
· Opinion
A Class I Label on a Software Patch Is a Test of How We Read Recalls -
· Devices & Diagnostics
FDA flags Boston Scientific Accolade pacemaker software fix as a Class I recall, covering 1.4 million implants -
· Devices & Diagnostics
B. Braun recalls 686,750 spinal anesthesia trays after Huons recalls the bupivacaine inside them -
· FDA & Regulatory
FDA grants salanersen Breakthrough Therapy status, an early step for Biogen's investigational once-yearly SMA drug -
· Devices & Diagnostics
FDA labels BD Pyxis cabinet recall Class II after fingerprint scanner found to overheat enough to burn users -
· Digital Health & AI
Artera sells a metastatic prostate-cancer mortality estimate on a validation it has not disclosed -
· FDA & Regulatory
FDA tells gene-therapy developers: stop re-proving what's already known -
· Devices & Diagnostics
FDA raises Bolton Medical's RelayPro thoracic stent-graft recall to Class I after three reported deaths -
· Research
Obexelimab more than halves IgG4-related disease flares in Phase 3 INDIGO trial -
· FDA & Regulatory
FDA Draft Guidance Would Let Gene-Therapy Developers Reuse Platform Data Across Genome-Editing Programs -
· Digital Health & AI
Philips puts AI auto-measurement and on-cart Koios on its general-imaging ultrasound -
· Devices & Diagnostics
FDA clears SpectralMD's DeepView through De Novo, creating a device class for AI burn imaging -
· Devices & Diagnostics
FDA clears Cardiosense software to estimate a heart-failure filling pressure without a catheter -
· Clinical Trials
Trodelvy misses overall-survival goal in Phase 3 bladder-cancer trial; Gilead withdrew the indication -
· FDA & Regulatory
FDA clears ensitrelvir to prevent COVID-19 after household exposure; NEJM trial showed 2.9% vs 9.0% infection -
· Biotech Business
Celcuity reports a PIK3CA-mutant breast cancer win for gedatolisib over alpelisib, with the actual numbers due at ASCO on June 2 -
· FDA & Regulatory
FDA grants accelerated approval to bulevirtide, the first US therapy for chronic hepatitis delta -
· FDA & Regulatory
FDA approves baxdrostat, the first aldosterone synthase inhibitor for hard-to-control hypertension -
· Public Health
WHO declares Bundibugyo Ebola a global emergency as DRC-Uganda outbreak tops 130 confirmed cases -
· Biotech Business
Daraxonrasib roughly doubles survival over chemotherapy in previously treated metastatic pancreatic cancer