Latest Breaking News On - Formal dispute resolution request - Page 1 : comparemela.com

Exxua: A Lengthy Approval Under a Regulatory Lens

Exxua: A Lengthy Approval Under a Regulatory Lens
pharmacytimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmacytimes.com Daily Mail and Mail on Sunday newspapers.

New yorkUnited statesClin psychopharmacolKaur gillMead johnsonBristol myers squibbFabre kramer phaemaceuticalsPsychopharmacologic drugs advisory committee meetingPsychopharmacologic drugs advisory committeeFabre kramer pharmaceuticals announcesEuropean medicines agencyFabre kramer pharmaceuticalsIntj health servDrug administrationBristol myers companyNew york times

FDA Approves Vadadustat (Vafseo) Tablets for Anemia Due to CKD in Adult Patients on Dialysis

FDA Approves Vadadustat (Vafseo) Tablets for Anemia Due to CKD in Adult Patients on Dialysis
hcplive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from hcplive.com Daily Mail and Mail on Sunday newspapers.

United statesJohnp butlerDrug administrationAkebia therapeuticsComplete response letterBoxed warningNew drug applicationPrescription drug user fee actFormal dispute resolution requestChronic kidney diseaseAdult patientsAnemia dueVadadustat resubmission

Akebia s CKD Anemia Drug Ends Tough Regulatory Path with FDA Approval

After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.

United statesJohn butlerOffice of new drugsAkebia therapeuticNew england journalComplete response letterFormal dispute resolution requestKebias ckd anemia drug ends tough regulatory path with fda approval

Cytokinetics Reports Fourth Quarter 2023 Financial Results

Cytokinetics Reports Fourth Quarter 2023 Financial Results
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

United statesJi xingRoberti blumCytokinetics diane weiserseniorOffice of new drugsOngoing researchResearch evaluation of sustained treatmentInternational symposiumExchange commissionUs food drug administrationCytokinetics incorporated nasdaqClinical developmentCommittee for medicinal products human useSkeletal muscle programCorporate communicationsEuropean medicines agency

Ardelyx Stock Q4: Recent Bull Run May Pause While Market Digests 2024 Guidance

Ardelyx Stock Q4: Recent Bull Run May Pause While Market Digests 2024 Guidance
seekingalpha.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from seekingalpha.com Daily Mail and Mail on Sunday newspapers.

Susan rodriguezBayer kerendiaOffice of cardiologyOffice of new drugsRenal drug advisory committeeArdelyx incMassachusetts based ardelyxIrritable bowel syndromeChronic kidney diseaseComplete response letterFormal dispute resolution requestNew drugsGuides for blockbuster ibsrelaBig pharmaIronwood pharmaceuticalSetbacks are common