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FDA Issues CRL for HEPLISAV-B in Adults on Hemodialysis

FDA Issues CRL for HEPLISAV-B in Adults on Hemodialysis
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United kingdomGreat britainRob janssenLinkedin rob janssenDrug administrationDrug administration for biologics license applicationEuropean unionComplete response letterBiologic license applicationEuropean commissionChief medical officerToll like receptorDynavax provides regulatory updateDynavax announcesDynavax receivesResponse letter

Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain

– Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and.

United statesCity ofUnited kingdomJessica oswaldReshma kewalramaniExchange commissionVertex pharmaceuticals conference callVertex pharmaceuticals incorporated nasdaqCompanies to workDrug administrationVertex pharmaceuticals incorporatedAcute pain following abdominoplastyBusiness wireNumeric pain rating scalePatients undergoingKey secondary outcomes

Vertex Pharma (VRTX) Reports Positive Results From the VX-548 Phase 3 Program

Vertex Pharma (VRTX) Reports Positive Results From the VX-548 Phase 3 Program
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United statesCity ofUnited kingdomReshma kewalramaniJessica oswaldCompanies to workDrug administrationVertex pharmaceuticals incorporated nasdaqVertex pharmaceuticals incorporatedVertex pharmaceuticals conference callExchange commissionNumeric pain rating scalePatients undergoingKey secondary outcomesAcute pain followingAcute pain following abdominoplasty

Can Cognitive Therapy - Trazadone Ease Dialysis Insomnia?

Examine why patients receiving hemodialysis did recover from insomnia when treated with Trazadone or cognitive behavioral therapy.

Ronaldb postumaUniversity of washingtonInternal medicineExisting insomnia therapiesPatients undergoingDialysis insomnia therapyInsomnia severity indexCognitive therapyLack of sleep

Eleven Potentially Practice-Changing Drugs Were Approved by the FDA in 2023

These drugs have interesting mechanisms, unique use, or may support expanded indications in the future.

United statesTreasure islandVonoprazan voqueznaZuranolone zurzuvaeDaprodustat jesduvroqGepirone exuaaTarsus pharmaceuticalsNational library of medicineSaturni study groupCenters for diseaseNational centerBausch health companiesFabre kramer pharmaceuticals announcesPhathom pharmaceuticalsMission pharmacal companyFabre kramer pharmaceuticals inc