FDA

After FDA's delayed hold for multiple myeloma drug, Molecular Templates is back in action
After FDA's delayed hold for multiple myeloma drug, Molecular Templates is back in action
Fierce Biotech
Molecular Templates
clinical trials
MT-0169
FDA
Multiple Myeloma
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FDA clears narrow use of Lynparza in prostate cancer, continuing ‘shift’ on PARP drugs
FDA clears narrow use of Lynparza in prostate cancer, continuing ‘shift’ on PARP drugs
BioPharma Dive
AstraZeneca
Merck
Lynparza
prostate cancer
FDA
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FDA hits iRhythm with warning letter over problems at heart monitor facility
FDA hits iRhythm with warning letter over problems at heart monitor facility
Medtech Dive
iRhythm Technologies
FDA
Medtech
heart monitors
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FDA approves Pfizer’s RSV vaccine for older adults
FDA approves Pfizer’s RSV vaccine for older adults
Stat
Pfizer
vaccines
FDA
elderly
RSV
Abrysvo
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GE HealthCare gets FDA nod for Precision DL image processing software
GE HealthCare gets FDA nod for Precision DL image processing software
Medical Device Network
GE Healthcare
FDA
deep learning
artificial intelligence
Medtech
imaging
Precision DL
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Go or no go? Key FDA decisions for Argenx and Regeneron
Go or no go? Key FDA decisions for Argenx and Regeneron
EP Vantage
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
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Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
Medical Marketing and Media
Neuralink
FDA
clinical trials
brain implants
Elon Musk
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Lexicon gets FDA approval for Inpefa to treat heart failure
Lexicon gets FDA approval for Inpefa to treat heart failure
Pharmaceutical Technology
Lexicon Pharmaceuticals
FDA
Inpefa
heart failure
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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA
FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA
Pharmaceutical Technology
Takeda
Hutchmed
FDA
fruquintinib
colorectal cancer
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FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
CNBC
Pfizer
Paxlovid
COVID-19
FDA
antivirals
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FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder
FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder
Fierce Pharma
Braeburn Pharmaceuticals
FDA
Brixadi
opioids
opioid use disorder
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Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro
Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro
Fierce Pharma
Innoviva
FDA
Entasis Therapeutics
Xacduro
ventilator-associated bacterial pneumonia
hospital-acquired bacterial pneumonia
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FDA delays decision on Duchenne gene therapy and considers narrower approval
FDA delays decision on Duchenne gene therapy and considers narrower approval
BioPharma Dive
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
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Immunovant Shares Touch 52-Week High After FDA Green Lights IMVT-1402 Study
Immunovant Shares Touch 52-Week High After FDA Green Lights IMVT-1402 Study
Marketwatch
Immunovant
immunology
IMVT-1402
autoimmune disease
FDA
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New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval
New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval
Stat
Opiant Pharmaceuticals
Opvee
FDA
opioid overdose
opioids
Fentanyl
Naloxone
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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Fierce Pharma
Blueprint Medicines
Ayvakit
FDA
indolent systemic mastocytosis
systemic mastocytosis
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Locate Bio receives FDA breakthrough designation for spinal fusion treatment
Locate Bio receives FDA breakthrough designation for spinal fusion treatment
Biopharma Reporter
Locate Bio
Orthopedics
FDA
LDGraft
spinal fusion
Medtech
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Sarepta Enters Uncharted Territory with Adcomm Approval
Sarepta Enters Uncharted Territory with Adcomm Approval
BioSpace
Sarepta Therapeutics
SRP-9001
DMD
Duchenne Muscular Dystrophy
FDA
gene therapy
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Thermo Fisher's biomarker blood tests to spot preeclampsia risk are first to win FDA nod
Thermo Fisher's biomarker blood tests to spot preeclampsia risk are first to win FDA nod
Fierce Biotech
Thermo Fisher Scientific
diagnostics
Medtech
FDA
preeclampsia
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Future of Intercept’s NASH drug in doubt after FDA panel rejection
Future of Intercept’s NASH drug in doubt after FDA panel rejection
BioPharma Dive
Intercept Pharma
FDA
NASH
obeticholic acid
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