FDA

Rigel bets $230M that Forma's leukemia drug gets in formation with FDA
Fierce Biotech
Tue, 08/2/22 - 11:30 pm
Rigel Pharmaceuticals
Forma Therapeutics
olutasidenib
leukemia
FDA
FDA extends Class I UDI submission deadline, exempts consumer health devices from requirements
Medtech Dive
Tue, 08/2/22 - 10:46 am
devices
Medtech
FDA
GUDID
Celyad gets the go-ahead to resume CAR-T trial for colorectal cancer as FDA lifts hold
Endpoints
Mon, 08/1/22 - 11:54 pm
Celyad
CAR-T
colorectal cancer
FDA
clinical trials
Concert to seek approval for hair loss drug after second study success
BioPharma Dive
Mon, 08/1/22 - 10:49 am
Concert Pharmaceuticals
FDA
hair loss
clinical trials
CTP-543
FDA halts testing of Beam’s base editing cancer therapy
BioPharma Dive
Mon, 08/1/22 - 10:45 am
Beam Therapeutics
clinical trials
FDA
gene editing
CRISPR
ImmunityBio’s Bladder Cancer Immunotherapy BLA gets FDA Nod
BioSpace
Mon, 08/1/22 - 10:29 am
ImmunityBio
FDA
N-803
bladder cancer
FDA signs off on Bavarian Nordic plant, allowing distribution of monkeypox vaccine doses
BioPharma Dive
Thu, 07/28/22 - 12:38 pm
Bavarian Nordic
monkeypox
vaccines
Denmark
FDA
Go or no go? J&J’s bispecific FDA first
EP Vantage
Thu, 07/28/22 - 11:04 am
JNJ
Amicus Therapeutics
Acadia Pharma
Bluebird Bio
FDA
FDA setback leads women’s health biotech ObsEva to give up on uterine fibroids drug
MedCity News
Wed, 07/27/22 - 06:43 pm
ObsEva
uterine fibroids
linzagolix
FDA
FDA, in another test of its flexibility, agrees to review Biogen’s closely watched ALS drug
BioPharma Dive
Tue, 07/26/22 - 11:08 am
Biogen
ALS
tofersen
FDA
Device approvals drop, but the FDA has a plan
EP Vantage
Tue, 07/26/22 - 11:00 am
FDA
devices
Medtech
device approvals
Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug
BioPharma Dive
Mon, 07/25/22 - 09:54 pm
Novartis
FDA
Biogen
biosimilars
Tysabri
MS
multiple sclerosis
QBiotics receives IND application approval for Phase II solid tumours therapy trial
Pharmaceutical Business Review
Mon, 07/25/22 - 10:47 am
QBiotics
clinical trials
FDA
tigilanol tiglate
solid tumors
FDA to expand use of remote regulatory assessments beyond the pandemic
Medtech Dive
Mon, 07/25/22 - 10:42 am
FDA
regulatory
pandemic
remote regulatory assessments
Medtech
Is the HIF-PHI class of next-generation kidney drugs doomed in the U.S.?
MedCity News
Mon, 07/25/22 - 10:33 am
HIF-PHI
kidney disease
FDA
vadadustat
iRhythm snags FDA approval for AFib characterization algorithm used in Verily’s wearable
MedCity News
Sun, 07/24/22 - 08:00 pm
iRhythm Technologies
Verily
devices
Medtech
atrial fibrillation
FDA
Drugmakers are slow to prove medicines that got a fast track to market really work
NPR
Sun, 07/24/22 - 07:52 pm
FDA
drug approvals
accelerated approvals
fast track
cancer
FDA reviewing higher dose Hyrimoz biosimilar
Biopharma Reporter
Fri, 07/22/22 - 11:14 am
FDA
Sandoz
biosimilars
Hyrimoz
Humira
AbbVie
Biosimilar inspections still lagging as the FDA looks to clear its backlog
Endpoints
Fri, 07/22/22 - 10:11 am
biosimilars
FDA
regulatory
regulatory inspections
Vertex Advances VX-548 in Acute and Neuropathic Pain
Yahoo/Businesswire
Fri, 07/22/22 - 10:09 am
Vertex Pharmaceuticals
acute pain
neuropathic pain
FDA
VS-548
clinical trials

Pages