FDA

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion
FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion
Endpoints
FDA
Emergent BioSolutions
regulatory inspections
drug manufacturing
vaccines
Flag link:
Regulatory progress for two biotechs stalls as FDA requests more information
Regulatory progress for two biotechs stalls as FDA requests more information
MedCity News
KalVista
Y-mAbs Therapeutics
FDA
KVD824
HAE
Flag link:
The next 2 months in biotech and pharma will be busy. Here's what to watch.
The next 2 months in biotech and pharma will be busy. Here's what to watch.
BioPharma Dive
Biogen
aducanumab
FDA
Vertex Pharmaceuticals
Sarepta Therapeutics
JNJ
AstraZeneca
vaccines
COVID-19
Flag link:
FDA slaps a hold on KalVis­ta's PhII study of an HAE drug, rais­ing a red flag on pre­clin­i­cal re­sults
FDA slaps a hold on KalVis­ta's PhII study of an HAE drug, rais­ing a red flag on pre­clin­i­cal re­sults
Endpoints
KalVista
HAE
FDA
clinical trials
KVD824
Flag link:
Am­gen's promis­ing gas­tric can­cer drug makes good on Five Prime po­ten­tial with FDA's break­through nod
Am­gen's promis­ing gas­tric can­cer drug makes good on Five Prime po­ten­tial with FDA's break­through nod
Endpoints
Amgen
clinical trials
gastric cancer
bemarituzumab
FDA
Flag link:
Anixa Hits FDA Speedbump for Ovarian Cancer CAR-T Trial Approval
Anixa Hits FDA Speedbump for Ovarian Cancer CAR-T Trial Approval
BioSpace
Anixa Biosciences
FDA
CAR-T
ovarian cancer
Flag link:
Bristol Myers’ Opdivo Receives FDA Approval for Gastric Cancer
Bristol Myers’ Opdivo Receives FDA Approval for Gastric Cancer
BioSpace
Bristol Myers Squibb
FDA
gastric cancer
Opdivo
Flag link:
FDA issues final rule removing certain software from medical device regulations
FDA issues final rule removing certain software from medical device regulations
RAPS.org
devices
21st Century Cures Act
FDA
software
Flag link:
Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions
Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions
Endpoints
Seagen
FDA
Padcev
Astellas
Flag link:
Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA
Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA
BioSpace
FDA
COVID-19
Janet Woodcock
Flag link:
FDA orders shutdown at Emergent's troubled plant 2 weeks after handing J&J the keys
FDA orders shutdown at Emergent's troubled plant 2 weeks after handing J&J the keys
Fierce Pharma
Emergent BioSolutions
drug manufacturing
vaccines
FDA
COVID-19
Flag link:
When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area
When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area
Endpoints
devices
FDA
Flag link:
FDA updates on ASCA pilot, lists accredited test labs
FDA updates on ASCA pilot, lists accredited test labs
RAPS.org
FDA
ASCA
devices
Flag link:
Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab
Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab
Reuters
Eli Lilly
FDA
antibodies
COVID-19
bamlanivimab
Flag link:
FDA walks back Trump-era premarket notification exemptions
FDA walks back Trump-era premarket notification exemptions
RAPS.org
FDA
regulatory
premarket notification pathway
Flag link:
Amylyx Pharma’s ALS drug needs a Phase 3 study to support FDA submission
Amylyx Pharma’s ALS drug needs a Phase 3 study to support FDA submission
MedCity News
Amylyx
ALS
clinical trials
FDA
Flag link:
Sponsors should flag decentralized aspects of cancer trials to prep for the post-Covid era, FDA says
Sponsors should flag decentralized aspects of cancer trials to prep for the post-Covid era, FDA says
Endpoints
FDA
oncology
clinical trials
decentralized clinical trials
Flag link:
Biden expands his list of potential nominees to lead FDA as pressure mounts to make a pick: WSJ
Biden expands his list of potential nominees to lead FDA as pressure mounts to make a pick: WSJ
Fierce Pharma
FDA
Joe Biden
Flag link:
FDA faces backlash after seeking more data on an experimental ALS therapy
FDA faces backlash after seeking more data on an experimental ALS therapy
BioPharma Dive
ALS
AMX0035
Amylyx Pharmaceuticals
FDA
Flag link:
Janet Woodcock on if the FDA is getting tougher on drug reviews: ‘I don’t think so’
Janet Woodcock on if the FDA is getting tougher on drug reviews: ‘I don’t think so’
Endpoints
FDA
Janet Woodcock
drug approvals
Flag link:

Pages