FDA

FDA clears narrow use of Lynparza in prostate cancer, continuing ‘shift’ on PARP drugs
BioPharma Dive
Thu, 06/1/23 - 11:53 am
AstraZeneca
Merck
Lynparza
prostate cancer
FDA
FDA hits iRhythm with warning letter over problems at heart monitor facility
Medtech Dive
Thu, 06/1/23 - 11:47 am
iRhythm Technologies
FDA
Medtech
heart monitors
FDA approves Pfizer’s RSV vaccine for older adults
Stat
Wed, 05/31/23 - 07:03 pm
Pfizer
vaccines
FDA
elderly
RSV
Abrysvo
GE HealthCare gets FDA nod for Precision DL image processing software
Medical Device Network
Wed, 05/31/23 - 11:02 am
GE Healthcare
FDA
deep learning
artificial intelligence
Medtech
imaging
Precision DL
Go or no go? Key FDA decisions for Argenx and Regeneron
EP Vantage
Wed, 05/31/23 - 10:51 am
FDA
Albireo Pharma
Aldeyra Therapeutics
Alvotech
Amneal Pharmaceuticals
Argenx
ARS Pharmaceuticals
AstraZeneca
Bayer
Bio-Thera Solutions
Biogen
BioMarin Pharmaceutical
Bristol Myers Squibb
Eisai
Eton Pharmaceuticals
F2G
Fabre-Kramer Pharmaceuticals
Fresenius
GSK
Intercept Pharmaceuticals
Ipsen
Ironwood Pharmaceuticals
Merck
Novaliq
Pfizer
Regeneron
Roche
Sanofi
Sarepta Therapeutics
Shionogi
Swedish Orphan Biovitrum
Takeda
Teva Pharmaceutica
UCB Pharma
Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
Medical Marketing and Media
Mon, 05/29/23 - 12:17 pm
Neuralink
FDA
clinical trials
brain implants
Elon Musk
Lexicon gets FDA approval for Inpefa to treat heart failure
Pharmaceutical Technology
Mon, 05/29/23 - 12:14 pm
Lexicon Pharmaceuticals
FDA
Inpefa
heart failure
FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA
Pharmaceutical Technology
Fri, 05/26/23 - 11:31 am
Takeda
Hutchmed
FDA
fruquintinib
colorectal cancer
FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
CNBC
Thu, 05/25/23 - 08:28 pm
Pfizer
Paxlovid
COVID-19
FDA
antivirals
FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder
Fierce Pharma
Wed, 05/24/23 - 06:38 pm
Braeburn Pharmaceuticals
FDA
Brixadi
opioids
opioid use disorder
Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro
Fierce Pharma
Wed, 05/24/23 - 11:25 am
Innoviva
FDA
Entasis Therapeutics
Xacduro
ventilator-associated bacterial pneumonia
hospital-acquired bacterial pneumonia
FDA delays decision on Duchenne gene therapy and considers narrower approval
BioPharma Dive
Wed, 05/24/23 - 11:21 am
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
Immunovant Shares Touch 52-Week High After FDA Green Lights IMVT-1402 Study
Marketwatch
Tue, 05/23/23 - 10:12 am
Immunovant
immunology
IMVT-1402
autoimmune disease
FDA
New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval
Stat
Mon, 05/22/23 - 10:09 pm
Opiant Pharmaceuticals
Opvee
FDA
opioid overdose
opioids
Fentanyl
Naloxone
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Fierce Pharma
Mon, 05/22/23 - 10:07 pm
Blueprint Medicines
Ayvakit
FDA
indolent systemic mastocytosis
systemic mastocytosis
Locate Bio receives FDA breakthrough designation for spinal fusion treatment
Biopharma Reporter
Mon, 05/22/23 - 11:32 am
Locate Bio
Orthopedics
FDA
LDGraft
spinal fusion
Medtech
Sarepta Enters Uncharted Territory with Adcomm Approval
BioSpace
Mon, 05/22/23 - 10:22 am
Sarepta Therapeutics
SRP-9001
DMD
Duchenne Muscular Dystrophy
FDA
gene therapy
Thermo Fisher's biomarker blood tests to spot preeclampsia risk are first to win FDA nod
Fierce Biotech
Mon, 05/22/23 - 10:19 am
Thermo Fisher Scientific
diagnostics
Medtech
FDA
preeclampsia
Future of Intercept’s NASH drug in doubt after FDA panel rejection
BioPharma Dive
Sun, 05/21/23 - 10:51 pm
Intercept Pharma
FDA
NASH
obeticholic acid
Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease
Fierce Pharma
Sun, 05/21/23 - 10:48 pm
Krystal Biotech
Vyjuvek
dystrophic epidermolysis bullosa
gene therapy
FDA

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