Dr. Ramachandran noted how “we’re just going to be living in uncertainty in terms of whether or not these drugs actually work.” Dr. Skydel noted how Tavneos “really shouldn’t remain on the market,” based on the law and how Amgen has fallen behind on postmarketing study deadlines (4/5)
October 29, 2026 at 7:59 PM
Dr. Ramachandran noted how “we’re just going to be living in uncertainty in terms of whether or not these drugs actually work.” Dr. Skydel noted how Tavneos “really shouldn’t remain on the market,” based on the law and how Amgen has fallen behind on postmarketing study deadlines (4/5)
🩸 Facts about Acute Hepatic Porphyria:
Givosiran-associated pancreatitis and postmarketing safety signals, hemin treatment risks, ALAS1 suppression, breakthrough attacks during therapy, and HCC risk and surveillance.
#AHP #AcuteHepaticPorphyria #Porphyria #Givosiran #Hemin #Hematology #HemeOnc
Givosiran-associated pancreatitis and postmarketing safety signals, hemin treatment risks, ALAS1 suppression, breakthrough attacks during therapy, and HCC risk and surveillance.
#AHP #AcuteHepaticPorphyria #Porphyria #Givosiran #Hemin #Hematology #HemeOnc
October 26, 2026 at 10:34 PM
🩸 Facts about Acute Hepatic Porphyria:
Givosiran-associated pancreatitis and postmarketing safety signals, hemin treatment risks, ALAS1 suppression, breakthrough attacks during therapy, and HCC risk and surveillance.
#AHP #AcuteHepaticPorphyria #Porphyria #Givosiran #Hemin #Hematology #HemeOnc
Givosiran-associated pancreatitis and postmarketing safety signals, hemin treatment risks, ALAS1 suppression, breakthrough attacks during therapy, and HCC risk and surveillance.
#AHP #AcuteHepaticPorphyria #Porphyria #Givosiran #Hemin #Hematology #HemeOnc
roles in vascular homeostasis and metabolic regulation. Postmarketing surveillance identified BP elevations in erenumab-treated patients, prompting a U. S. (🧵 2/12)
October 26, 2026 at 9:41 AM
roles in vascular homeostasis and metabolic regulation. Postmarketing surveillance identified BP elevations in erenumab-treated patients, prompting a U. S. (🧵 2/12)
Use of dupilumab (Dupixent) in pregnancy appeared safe for the baby, a postmarketing registry study showed. #CHEST2026
@accpchest.bsky.social
https://www.medpagetoday.com/meetingcoverage/chest/123517
@accpchest.bsky.social
https://www.medpagetoday.com/meetingcoverage/chest/123517
Dupilumab Use During Pregnancy Appeared Safe for Babies
Prospective registry study shows no increase in birth defects
www.medpagetoday.com
October 22, 2026 at 2:46 PM
Use of dupilumab (Dupixent) in pregnancy appeared safe for the baby, a postmarketing registry study showed. #CHEST2026
@accpchest.bsky.social
https://www.medpagetoday.com/meetingcoverage/chest/123517
@accpchest.bsky.social
https://www.medpagetoday.com/meetingcoverage/chest/123517
#PhaseIV ≠ #RealWorldEvidence.
Phase IV: interventional trial, prospective protocol, mandated by regulators.
#RWE: observational, answers what trials can't.
Neither substitutes for the other.
#PostMarketing #Pharmacovigilance #ClinicalResearch #DrugDevelopment #CRO #ICHM14 #FDA #EMA
Phase IV: interventional trial, prospective protocol, mandated by regulators.
#RWE: observational, answers what trials can't.
Neither substitutes for the other.
#PostMarketing #Pharmacovigilance #ClinicalResearch #DrugDevelopment #CRO #ICHM14 #FDA #EMA
Phase IV vs Real-World Evidence: Two Different Tools That Solve Two Different Problems
Phase IV and real-world evidence are not interchangeable. Phase IV is an interventional trial mandated by FDA or EMA — RWE cannot substitute it.
genelifecr.blogspot.com
October 21, 2026 at 7:01 AM
#PhaseIV ≠ #RealWorldEvidence.
Phase IV: interventional trial, prospective protocol, mandated by regulators.
#RWE: observational, answers what trials can't.
Neither substitutes for the other.
#PostMarketing #Pharmacovigilance #ClinicalResearch #DrugDevelopment #CRO #ICHM14 #FDA #EMA
Phase IV: interventional trial, prospective protocol, mandated by regulators.
#RWE: observational, answers what trials can't.
Neither substitutes for the other.
#PostMarketing #Pharmacovigilance #ClinicalResearch #DrugDevelopment #CRO #ICHM14 #FDA #EMA
“Vaccination programs may consider providing clear, balanced information on expected benefits, common mild adverse events, and postmarketing safety monitoring.”
October 14, 2026 at 9:55 PM
“Vaccination programs may consider providing clear, balanced information on expected benefits, common mild adverse events, and postmarketing safety monitoring.”
New clinical trial
A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Imp...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Imp...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (...
The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants fro...
brain-regeneration.com
October 8, 2026 at 5:40 PM
New clinical trial
A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Imp...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Imp...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
“Merck did the long, costly work required to fulfill a pediatric postmarketing requirement and expand Recarbrio’s label to children weighing as little as 2 kilograms,” Skinner said. /1
Merck pulls antibiotic from US market
The drugmaker says it will no longer manufacture or market the combination antibiotic Recarbrio in the US.
Read more: https://bit.ly/4AGxJnB
The drugmaker says it will no longer manufacture or market the combination antibiotic Recarbrio in the US.
Read more: https://bit.ly/4AGxJnB
September 29, 2026 at 9:45 PM
“Merck did the long, costly work required to fulfill a pediatric postmarketing requirement and expand Recarbrio’s label to children weighing as little as 2 kilograms,” Skinner said. /1
Real-world data from 133 avacopan-treated and 458 control ANCA-associated vasculitis patients showed a small excess of ALT elevation with avacopan, with no vanishing bile duct syndrome observed and similar hospitalization and one-year mortality
Research letter in A&R
doi.org/10.1002/art....
Research letter in A&R
doi.org/10.1002/art....
September 27, 2026 at 6:26 PM
Real-world data from 133 avacopan-treated and 458 control ANCA-associated vasculitis patients showed a small excess of ALT elevation with avacopan, with no vanishing bile duct syndrome observed and similar hospitalization and one-year mortality
Research letter in A&R
doi.org/10.1002/art....
Research letter in A&R
doi.org/10.1002/art....
Best of: Often the FDA will mandate postmarketing studies to prove the safety of newly approved drugs and devices. Those can take years to complete while profits pile up. Soon, it could get even worse. bit.ly/4y8An3N
The Drugs And Devices Have Been On The Market For Years. But FDA-Ordered Studies Still Aren't Done.
TUESDAY, Sept. 22, 2026 (HealthDay News) — When the U.S. Food and Drug Administration (FDA) was deciding whether to approve the drug Tavneos several years ago t
bit.ly
September 27, 2026 at 8:12 PM
Best of: Often the FDA will mandate postmarketing studies to prove the safety of newly approved drugs and devices. Those can take years to complete while profits pile up. Soon, it could get even worse. bit.ly/4y8An3N
New clinical trial
A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diag...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diag...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diagnostics [ALZ-NET] Registry Data)
The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, ...
brain-regeneration.com
September 26, 2026 at 5:50 PM
New clinical trial
A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diag...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diag...
#ClinicalTrials #AlzheimersDisease #EndAlz #Neurology
Often the FDA will mandate postmarketing studies to prove the safety of newly approved drugs and devices. Those can take years and years to complete while profits pile up. Soon, it could get even worse. bit.ly/4y8An3N
The Drugs And Devices Have Been On The Market For Years. But FDA-Ordered Studies Still Aren't Done.
TUESDAY, Sept. 22, 2026 (HealthDay News) — When the U.S. Food and Drug Administration (FDA) was deciding whether to approve the drug Tavneos several years ago t
bit.ly
September 22, 2026 at 1:08 PM
Often the FDA will mandate postmarketing studies to prove the safety of newly approved drugs and devices. Those can take years and years to complete while profits pile up. Soon, it could get even worse. bit.ly/4y8An3N
The FDA is funded by applicants. This is why that is a bad idea.
FDA-Ordered Studies for Drugs and Devices on the Market for Years Still Aren't Done www.medpagetoday.com/publichealth...
FDA-Ordered Studies for Drugs and Devices on the Market for Years Still Aren't Done www.medpagetoday.com/publichealth...
FDA-Ordered Studies for Drugs and Devices on the Market for Years Still Aren't Done
Agency's reliance on postmarketing studies reflects a balancing act
www.medpagetoday.com
September 19, 2026 at 2:57 AM
The FDA is funded by applicants. This is why that is a bad idea.
FDA-Ordered Studies for Drugs and Devices on the Market for Years Still Aren't Done www.medpagetoday.com/publichealth...
FDA-Ordered Studies for Drugs and Devices on the Market for Years Still Aren't Done www.medpagetoday.com/publichealth...
Shingrix shows why approval is only the start of a regulatory lifecycle.
Its story now includes expanded use, long-term effectiveness data, postmarketing safety evidence, and continued product evolution.
Our latest analysis:
www.regulatoryimpact.com/insights/us-...
Its story now includes expanded use, long-term effectiveness data, postmarketing safety evidence, and continued product evolution.
Our latest analysis:
www.regulatoryimpact.com/insights/us-...
Shingles in the United States: Regulatory History, 2026 Market, and Treatment Landscape
The U.S. shingles landscape is anchored by a recombinant vaccine with nearly a decade of regulatory history, subsequent indication expansion, postmarketing safety actions, and continued label evolutio...
www.regulatoryimpact.com
September 16, 2026 at 12:33 PM
Shingrix shows why approval is only the start of a regulatory lifecycle.
Its story now includes expanded use, long-term effectiveness data, postmarketing safety evidence, and continued product evolution.
Our latest analysis:
www.regulatoryimpact.com/insights/us-...
Its story now includes expanded use, long-term effectiveness data, postmarketing safety evidence, and continued product evolution.
Our latest analysis:
www.regulatoryimpact.com/insights/us-...
New Postmarketing Safety Analysis of BRIXADI® Published in JSAT Highlights Adverse Events#USA#Plymouth_Meeting#Opioid_Treatment#BRIXADI#Braeburn
New Postmarketing Safety Analysis of BRIXADI® Published in JSAT Highlights Adverse Events
Braeburn's recent study published in the Journal of Substance Use & Addiction Treatment provides critical insights on safety data of BRIXADI®, focusing on adverse events reported since its U.S. launch.
third-news.com
September 15, 2026 at 1:43 PM
New Postmarketing Safety Analysis of BRIXADI® Published in JSAT Highlights Adverse Events#USA#Plymouth_Meeting#Opioid_Treatment#BRIXADI#Braeburn
Each year I see fewer people talking about it so -- updated COVID vaccines were approved by the FDA on August 27, including the 2026-27 update of NUVAXOVID
The updated vaccines target XFG (Stratus); doses of all three (Novavax/Sanofi, Pfizer, and Moderna) will be rolling out to pharmacies this week
The updated vaccines target XFG (Stratus); doses of all three (Novavax/Sanofi, Pfizer, and Moderna) will be rolling out to pharmacies this week
August 30, 2026 at 8:10 PM
Each year I see fewer people talking about it so -- updated COVID vaccines were approved by the FDA on August 27, including the 2026-27 update of NUVAXOVID
The updated vaccines target XFG (Stratus); doses of all three (Novavax/Sanofi, Pfizer, and Moderna) will be rolling out to pharmacies this week
The updated vaccines target XFG (Stratus); doses of all three (Novavax/Sanofi, Pfizer, and Moderna) will be rolling out to pharmacies this week
💬 Perspective by Daniel Prior, MD, and Lakshmanan Krishnamurti, MD: Excluding patients with #HIV from #SickleCellDisease gene therapy may perpetuate inequities in access to treatment and supports prospective inclusion in future trials and postmarketing registries.
ja.ma/3SDqY4S
ja.ma/3SDqY4S
August 19, 2026 at 6:35 PM
💬 Perspective by Daniel Prior, MD, and Lakshmanan Krishnamurti, MD: Excluding patients with #HIV from #SickleCellDisease gene therapy may perpetuate inequities in access to treatment and supports prospective inclusion in future trials and postmarketing registries.
ja.ma/3SDqY4S
ja.ma/3SDqY4S
Maximilian Siebert and colleagues evaluate the use of postmarketing requirements under the FDA Amendments Act and postmarketing commitments issued by the US FDA, for new drugs approved from 2016 to 2024.
https://bit.ly/4qjgHas
https://bit.ly/4qjgHas
Completion and outcomes of postmarketing requirements and commitments issued by the US Food and Drug Administration for new drugs, 2016-24: cross sectional evaluation of postmarketing studies
Objectives To evaluate the use of postmarketing requirements under the FDA Amendments Act (FDAAA) and postmarketing commitments issued by the US Food and Drug Administration (FDA), for new drugs appro...
bmjmedicine.bmj.com
August 17, 2026 at 7:12 PM
Maximilian Siebert and colleagues evaluate the use of postmarketing requirements under the FDA Amendments Act and postmarketing commitments issued by the US FDA, for new drugs approved from 2016 to 2024.
https://bit.ly/4qjgHas
https://bit.ly/4qjgHas
MannKind released from FDA postmarketing trial requirement for Afrezza diabetes drug
$MNKD 8-K → https://filingdiff.com/ticker/MNKD/0001193125-26-243074/
$MNKD 8-K → https://filingdiff.com/ticker/MNKD/0001193125-26-243074/
May 28, 2026 at 5:10 PM
MannKind released from FDA postmarketing trial requirement for Afrezza diabetes drug
$MNKD 8-K → https://filingdiff.com/ticker/MNKD/0001193125-26-243074/
$MNKD 8-K → https://filingdiff.com/ticker/MNKD/0001193125-26-243074/
If you’re older as I am and are thinking of getting an RSV vaccine there is an increased incidence of GBS within the first 42 days post-injection. Check this out:
www.cidrap.umn.edu/respiratory-...
www.cidrap.umn.edu/respiratory-...
FDA requires Guillain-Barre label warnings for 2 RSV vaccines
The change was prompted by postmarketing observational studies that suggest an increased risk of GBS within 42 days of vaccination.
www.cidrap.umn.edu
January 8, 2025 at 10:09 PM
If you’re older as I am and are thinking of getting an RSV vaccine there is an increased incidence of GBS within the first 42 days post-injection. Check this out:
www.cidrap.umn.edu/respiratory-...
www.cidrap.umn.edu/respiratory-...