Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
1,100 of 1,100 tracked regulatory updates from 40 agencies and publishers, page 16 of 22.
A Costly 180: The D.C. Circuit Flips FDA’s Forfeiture PlaybookHyman, Phelps & McNamara (FDA Law)Top Ten Essentials for Preventing Hospital Controlled Substance DiversionHyman, Phelps & McNamara (FDA Law)FDA Addresses Device Constituents in New Draft Guidance on Container Closure SystemsHyman, Phelps & McNamara (FDA Law)FDA’s Expedited IND Pilot Comes Into FocusHyman, Phelps & McNamara (FDA Law)Hyman, Phelps & McNamara, P.C. Congratulates 15 Attorneys Named to The Best Lawyers in America® 2027 EditionHyman, Phelps & McNamara (FDA Law)One Noncompliant Healthcare System Is Remediating its Controlled Substance DeficienciesHyman, Phelps & McNamara (FDA Law)A New FDA Tobacco Enforcement Guidance Lawsuit: AAP Déjà Vu All Over Again, or Not?Hyman, Phelps & McNamara (FDA Law)RAPID Device Coverage: A Narrow Bridge Over Medicare’s Coverage GapHyman, Phelps & McNamara (FDA Law)FDA Turns the Spotlight on Regulatory Science: What Medical Device Developers Need to KnowHyman, Phelps & McNamara (FDA Law)When the Label Lags the Science: Using 505(o)(4) to Compel Labeling ChangesHyman, Phelps & McNamara (FDA Law)The QMSR is Here: FDA’s First QMSR Warning LettersHyman, Phelps & McNamara (FDA Law)When the Math Isn’t Mathin’: FDA’s Latest Clinical Investigator Warning Letter Highlights Why Drug Accountability MattersHyman, Phelps & McNamara (FDA Law)Second Time’s the Charm: HRSA Revives the 340B Rebate PilotHyman, Phelps & McNamara (FDA Law)Medical Device Regulatory Expert — Hyman, Phelps & McNamara, P.C. (Washington, D.C.)Hyman, Phelps & McNamara (FDA Law)The FDA AdComm Reboot: Part 2; Lessons from the Meeting on Replimune’s RP1Hyman, Phelps & McNamara (FDA Law)Wegovy and Mounjaro for weight loss not fundedPharmac New ZealandAgenda for November 2026 Pharmacology and Therapeutics advisory committee (PTAC) meetingPharmac New ZealandAgenda for November 2026 Mental Health Advisory Committee meetingPharmac New ZealandPharmac funds a new medicine for people in hospital with serious infections and improves access to medicines for bacterial infections and high blood pressurePharmac New ZealandWidened access to diabetes medicines to benefit over 30,000 New ZealandersPharmac New ZealandStrengthening the Pharmaceutical SchedulePharmac New ZealandNext stage of Pharmac improvement programme underwayPharmac New ZealandImproving the assessment of medical devicesPharmac New ZealandChanges to support increased access to Estradiol TDP Mylan amid ongoing Estradot supply constraintsPharmac New ZealandBringing funded flu vaccines forward for under 5sPharmac New ZealandAgenda for October 2026 Gastrointestinal Advisory Committee meetingPharmac New ZealandAgenda for October 2026 Cardiovascular Advisory Committee meetingPharmac New ZealandPharmac expands access to funded cancer medicines for adolescents and young adultsPharmac New ZealandPharmac opens recruitment for new Community and Patient Advisory CommitteePharmac New ZealandPharmac seeks feedback on widening access to febuxostat for people with goutPharmac New ZealandPharmac proposal to improve access to medicines for people with high blood pressure and bacterial infectionsPharmac New ZealandAgenda for November 2026 Cancer Treatments (CTAC) meetingPharmac New ZealandFlu vaccine now funded for all children under five as influenza cases risePharmac New ZealandFlu vaccine funded for children under five for 2027 flu seasonPharmac New ZealandAgenda for October 2026 Cancer Treatments (CTAC) meetingPharmac New ZealandPharmac makes access to Estradiol TDP Mylan (oestradiol) patches easier for New ZealandersPharmac New Zealand2025/26 Pharmac Letter of Expectations progress update | July 2026Pharmac New ZealandAgenda for September 2026 Immunisation Advisory Committee (IAC) meetingPharmac New Zealand2026 deadline for submitting applications concerning clinical trialsDanish Medicines AgencyMedicine Prices and Product Range Around Christmas and New Year 2026/2027Danish Medicines AgencyProduct information to be updated for phenobarbital medicines used to treat epilepsy in animalsDanish Medicines AgencyThe go-live of the CTIS safety module has been postponedDanish Medicines AgencyGuidance on Complex Clinical Trials and Seasonal Vaccine TrialsDanish Medicines AgencyNew Safety Module in the Clinical Trials Information System (CTIS)Danish Medicines AgencyAre you working with the non-clinical package for clinical trial applications? See Q&A-update!Danish Medicines AgencyJoin the Danish Medicines Agency’s ATMP Open HouseDanish Medicines Agency[SHINSA]Basic Principles for the Use of AI in Regulatory Activities（Early Consideration） posted.PMDA Japan[KOKUSAI]PMDA-ATC Learning Videos contents have been updatedPMDA Japan[ANZEN]PMDA Alert for Proper Use of Drugs: Request for Proper Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists postedPMDA Japan[SHINSA]English Translation of Review Report: ZurzuvaePMDA Japan