Search form
Search
contact us
Navigation
home
boards
Jobs
job ratings
cp wire
medtech news
pharmagather
catering
advertise
whistleblower info
pharmaceutical fraud
medical device | DME fraud
clinical lab fraud
False Claims Act
Legal Help
login/register
You are here
Home
»
companies
» FDA
FDA
After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US
Fierce Pharma
Mon, 03/18/24 - 05:16 pm
Orchard Therapeutics
Kyowa Kirin
M&A
Lenmeldy
FDA
metachromatic leukodystrophy
Becoming ‘biologic-like’: CAR-T makers on quest to scale drugs’ production
Medical Marketing and Media
Mon, 03/18/24 - 05:13 pm
CAR-T
FDA
drug development
Despite early death concerns, FDA advisers back J&J and Legend's Carvykti and BMS' Abecma for earlier myeloma
Fierce Pharma
Sun, 03/17/24 - 09:30 pm
JNJ
Legend Biotech
CAR-T
FDA
Carvykti
Abecma
Not a Moment Too Soon: FDA Clears Intuitive Surgical's New Robot
Medical Devices and Diagnostics Industry
Sun, 03/17/24 - 09:23 pm
Medtech
FDA
Intuitive Surgical
da Vinci 5
robotic surgery
BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia
BioSpace
Fri, 03/15/24 - 11:32 am
Bristol Myers Squibb
CAR-T
CLL
Breyanzi
FDA
JNJ
Carvykti
Madrigal wins FDA approval of first drug for MASH
BioPharma Dive
Thu, 03/14/24 - 06:27 pm
Madrigal Pharmaceuticals
FDA
Rezdiffra
MASH
NASH
Geron's blood disorder drug gets FDA advisers' backing
Reuters
Thu, 03/14/24 - 06:26 pm
Geron
FDA
imetelstat
FDA approves expanded use of Mirum's liver disease drug
Reuters
Wed, 03/13/24 - 10:40 pm
Mirum Pharmaceuticals
FDA
liver disease
PFIC
FDA staff raises concerns over data from J&J, Bristol's CAR-T therapies
Reuters
Wed, 03/13/24 - 10:46 am
FDA
JNJ
Bristol Myers Squibb
blood cancers
cell therapy
Geron faces uphill battle at FDA meeting as agency questions benefit-risk profile of imetelstat
Fierce Biotech
Wed, 03/13/24 - 10:37 am
Geron
FDA
imetelstat
blood cancers
FDA guidelines consider amyloid reduction 'reasonably likely' to predict Alzheimer's benefit
Fierce Biotech
Tue, 03/12/24 - 11:34 am
Biogen
Eisai
Aduhelm
FDA
Alzheimer's disease
amyloid
Eli Lilly
donanemab
Johnson & Johnson files sBLA for ulcerative colitis treatment
Pharmaceutical Business Review
Tue, 03/12/24 - 11:19 am
JNJ
FDA
Tremfya
ulcerative colitis
FDA staff raises concerns on Geron's blood disorder drug
Reuters
Tue, 03/12/24 - 11:06 am
Geron
FDA
imetelstat
myelodysplastic syndrome
Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color
Fierce Biotech
Mon, 03/11/24 - 05:11 pm
Eli Lilly
eczema
lebrikizumab
FDA
Biden Administration Requests $7.13Bn FDA Budget For FY2025, Includes $3.3Bn In User Fees
Medtech Insight
Mon, 03/11/24 - 05:02 pm
FDA
user fees
Neuralink's Animal Experiments Under FDA Fire
Medical Devices and Diagnostics Industry
Mon, 03/11/24 - 05:00 pm
Neuralink
Elon Musk
FDA
animal research
FDA Adcomm to Tackle Complexity of CAR-T for Multiple Myeloma
BioSpace
Mon, 03/11/24 - 11:53 am
CAR-T
Multiple Myeloma
FDA
Bristol Myers Squibb
2seventy bio
Abecma
JNJ
Legend Biotech
Carvykti
Viatris' launch plans scuttled as FDA rebuffs long-acting MS drug from partner Mapi
Fierce Pharma
Mon, 03/11/24 - 11:32 am
Viatris
FDA
Mapi Pharma
MS
multiple sclerosis
glatiramer acetate depot
FDA clears use of Novo’s obesity drug to protect heart health
BioPharma Dive
Sun, 03/10/24 - 08:43 pm
Novo Nordisk
FDA
Wegovy
Fresenius Kabi’s Biosimilar for Actemra Gets FDA Approval
BioSpace
Sun, 03/10/24 - 08:25 pm
Fresenius Kabi
FDA
biosimilars
Actemra
Tyenne
Genentech
Pages
1
2
3
4
5
6
7
8
9
…
next ›
last »