My PDUFA date has been delayed because my IND was put on clinical hold. What should I do?
June 17, 2025 at 9:59 PM
My PDUFA date has been delayed because my IND was put on clinical hold. What should I do?
To expand on my message this morning, the FDA published their own fucking hiring data yesterday. Théir OWN FUCKING DATA says they are lying about hiring! 🧵🧵🧵
You can read the report here: www.fda.gov/industry/pre...
You can read the report here: www.fda.gov/industry/pre...
February 12, 2026 at 5:49 PM
To expand on my message this morning, the FDA published their own fucking hiring data yesterday. Théir OWN FUCKING DATA says they are lying about hiring! 🧵🧵🧵
You can read the report here: www.fda.gov/industry/pre...
You can read the report here: www.fda.gov/industry/pre...
As I was reading this, one of my coworkers sent out a farewell email 🙃 www.fiercebiotech.com/biotech/fda-...
Marty Makary talks DOGE cuts, new voucher program and why FDA still 'on track' to meet all PDUFA dates
All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report that we're on track to meet all the PDUFA targets, and that morale is good...
www.fiercebiotech.com
June 20, 2025 at 5:18 PM
As I was reading this, one of my coworkers sent out a farewell email 🙃 www.fiercebiotech.com/biotech/fda-...
“Ensitrelvir is currently under review by the U.S. Food and Drug Administration (FDA) for the prevention of COVID‑19 following exposure, with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2026...”
March 30, 2026 at 4:50 PM
“Ensitrelvir is currently under review by the U.S. Food and Drug Administration (FDA) for the prevention of COVID‑19 following exposure, with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2026...”
Great point. PDUFA (1992) authorizes the FDA to collect fees to cover the review of new drug applications. Companies pay upfront. There is no "budget" justification for cutting the service. This deserves pointed questioning by journalists.
April 2, 2025 at 3:57 PM
Great point. PDUFA (1992) authorizes the FDA to collect fees to cover the review of new drug applications. Companies pay upfront. There is no "budget" justification for cutting the service. This deserves pointed questioning by journalists.
Even if the executive order is dialed back or shelved, former FDA staff expect rigid back to work order would lead to exodus, causing missed PDFUFA goals. biocentury.com/article/654941
Downsizing could cause FDA to miss PDUFA goals
Current and former FDA officials warn that Trump administration personnel policies could cripple the agency’s ability to meet user fee goals for dru...
biocentury.com
February 7, 2025 at 12:53 PM
Even if the executive order is dialed back or shelved, former FDA staff expect rigid back to work order would lead to exodus, causing missed PDFUFA goals. biocentury.com/article/654941
Novavax says its COVID-19 vaccine is on track for FDA approval. The agency requested more post-approval clinical data, and the company plans to respond quickly to secure full authorization.
ir.novavax.com/press-releas...
ir.novavax.com/press-releas...
Latest update on U.S. FDA BLA for Novavax's COVID-19 Vaccine - Apr 23, 2025
We believe our BLA is approvable and are working with the FDA to address a PMC request received post-PDUFA to move toward final approval.
ir.novavax.com
April 23, 2025 at 1:56 PM
Novavax says its COVID-19 vaccine is on track for FDA approval. The agency requested more post-approval clinical data, and the company plans to respond quickly to secure full authorization.
ir.novavax.com/press-releas...
ir.novavax.com/press-releas...
FDA ADVISORY COMMITTEE UNANIMOUSLY BACKS MODERNA'S MRNA-1010 SEASONAL FLU VACCINE; PDUFA GOAL DATE REMAINS AUGUST 5, 2026.
June 18, 2026 at 8:11 PM
FDA ADVISORY COMMITTEE UNANIMOUSLY BACKS MODERNA'S MRNA-1010 SEASONAL FLU VACCINE; PDUFA GOAL DATE REMAINS AUGUST 5, 2026.
JESUS Ed you can't just ASK about a PDUFA in PUBLIC where everyone can SEE
June 18, 2025 at 7:41 AM
JESUS Ed you can't just ASK about a PDUFA in PUBLIC where everyone can SEE
#TeamVernunft #TeamScience #ImpfenSchützt #Impfung
🧵1/x Wie #Novavax gg. 14 Uhr MESZ auf der Website bekannt gab, verzögert sich die vollständige Zulassung des #Covid19 #Impfstoffes #Nuvaxovid durch die #FDA abermals.
Englisch:
➡️ ir.novavax.com/press-releas...
(Bitte Folgepostings weiterlesen.⤵️)
🧵1/x Wie #Novavax gg. 14 Uhr MESZ auf der Website bekannt gab, verzögert sich die vollständige Zulassung des #Covid19 #Impfstoffes #Nuvaxovid durch die #FDA abermals.
Englisch:
➡️ ir.novavax.com/press-releas...
(Bitte Folgepostings weiterlesen.⤵️)
April 23, 2025 at 12:34 PM
#TeamVernunft #TeamScience #ImpfenSchützt #Impfung
🧵1/x Wie #Novavax gg. 14 Uhr MESZ auf der Website bekannt gab, verzögert sich die vollständige Zulassung des #Covid19 #Impfstoffes #Nuvaxovid durch die #FDA abermals.
Englisch:
➡️ ir.novavax.com/press-releas...
(Bitte Folgepostings weiterlesen.⤵️)
🧵1/x Wie #Novavax gg. 14 Uhr MESZ auf der Website bekannt gab, verzögert sich die vollständige Zulassung des #Covid19 #Impfstoffes #Nuvaxovid durch die #FDA abermals.
Englisch:
➡️ ir.novavax.com/press-releas...
(Bitte Folgepostings weiterlesen.⤵️)
$BBIO BridgeBio halted. An approval decision for its amyloidosis therapy is likely, a week ahead of its PDUFA date.
November 22, 2024 at 9:18 PM
$BBIO BridgeBio halted. An approval decision for its amyloidosis therapy is likely, a week ahead of its PDUFA date.
Wait till some quarterly report shows fewer meetings granted and falling PDUFA timeline compliance.
March 19, 2025 at 1:51 PM
Wait till some quarterly report shows fewer meetings granted and falling PDUFA timeline compliance.
For those who don't know, PDUFA is the Prescription Drug User Fee Act, which authorizes the FDA to collect a fee from the entity (us. pharma firm) submitting a drug application to cover some of the costs of review. PDUFA is also a target date by which the FDA expects to have completed its approval.
April 2, 2025 at 3:53 PM
For those who don't know, PDUFA is the Prescription Drug User Fee Act, which authorizes the FDA to collect a fee from the entity (us. pharma firm) submitting a drug application to cover some of the costs of review. PDUFA is also a target date by which the FDA expects to have completed its approval.
Vanda (#$VNDA): Imsidolimab PDUFA Set for December 12, 2026
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/vanda-pharma...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/vanda-pharma...
September 23, 2026 at 9:31 PM
Vanda (#$VNDA): Imsidolimab PDUFA Set for December 12, 2026
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/vanda-pharma...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/vanda-pharma...
Sparsentan for FSGS?? It's alive....
ir.travere.com/press-releas...
ir.travere.com/press-releas...
Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS
PDUFA target action date of January 13, 2026 If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Travere Th...
ir.travere.com
May 20, 2025 at 5:53 PM
Sparsentan for FSGS?? It's alive....
ir.travere.com/press-releas...
ir.travere.com/press-releas...
Xspray Pharma inför PDUFA 7 oktober , synar @experten88.bsky.social den ? , guida mig 🙏 ?
September 2, 2025 at 9:00 AM
Xspray Pharma inför PDUFA 7 oktober , synar @experten88.bsky.social den ? , guida mig 🙏 ?
PolyPid (#$PYPD): D-PLEX100 Under Priority Review, PDUFA November 28
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/polypid-pypd...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/polypid-pypd...
September 23, 2026 at 4:55 PM
PolyPid (#$PYPD): D-PLEX100 Under Priority Review, PDUFA November 28
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/polypid-pypd...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/polypid-pypd...
INOVIO (#$INO): FDA Inspections Complete Ahead of October 30 PDUFA
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/inovio-pharm...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/inovio-pharm...
September 23, 2026 at 4:47 PM
INOVIO (#$INO): FDA Inspections Complete Ahead of October 30 PDUFA
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/inovio-pharm...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/inovio-pharm...
1) FEAR: Moderna major bird flu vax contract at risk, now losing share price
2) FEAR: losing access to FDA if/when PDUFA is compromised
3) HOPE: maybe GLP1 can be kept off Medicare price negotiations
4) DENIAL: they think Trump is pro-business
2) FEAR: losing access to FDA if/when PDUFA is compromised
3) HOPE: maybe GLP1 can be kept off Medicare price negotiations
4) DENIAL: they think Trump is pro-business
March 3, 2025 at 2:43 AM
1) FEAR: Moderna major bird flu vax contract at risk, now losing share price
2) FEAR: losing access to FDA if/when PDUFA is compromised
3) HOPE: maybe GLP1 can be kept off Medicare price negotiations
4) DENIAL: they think Trump is pro-business
2) FEAR: losing access to FDA if/when PDUFA is compromised
3) HOPE: maybe GLP1 can be kept off Medicare price negotiations
4) DENIAL: they think Trump is pro-business
Agios (#$AGIO): Mitapivat Q2 Revenue More Than Doubles, Sickle Cell PDUFA November 1
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/agios-pharma...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/agios-pharma...
September 23, 2026 at 4:23 PM
Agios (#$AGIO): Mitapivat Q2 Revenue More Than Doubles, Sickle Cell PDUFA November 1
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/agios-pharma...
Free Biotech Catalyst Calendar on Merlintrader.
www.merlintrader.com/agios-pharma...
And I thought I was going to get a head start on covering this in advance of the June 19 PDUFA date. Great news -- all efforts now need to focus on access in the wake of HIV prevention funding cuts in the US & worldwide.
www.gilead.com/news/news-de...
www.gilead.com/news/news-de...
June 18, 2025 at 7:58 PM
And I thought I was going to get a head start on covering this in advance of the June 19 PDUFA date. Great news -- all efforts now need to focus on access in the wake of HIV prevention funding cuts in the US & worldwide.
www.gilead.com/news/news-de...
www.gilead.com/news/news-de...