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FDA

FDA approves Pfizer’s RSV vaccine for older adults

FDA approves Pfizer’s RSV vaccine for older adults

Stat

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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

artificial intelligence

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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

clinical trials

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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

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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

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

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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

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

Entasis Therapeutics

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

Duchenne Muscular Dystrophy

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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

autoimmune disease

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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

opioid overdose

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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

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

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Sarepta Enters Uncharted Territory with Adcomm Approval

Sarepta Enters Uncharted Territory with Adcomm Approval

BioSpace

Sarepta Therapeutics

Duchenne Muscular Dystrophy

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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

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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

obeticholic acid

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal Biotech

dystrophic epidermolysis bullosa

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AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Fierce Pharma

diffuse large B-cell lymphoma

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Galera earns key FDA designation for pancreatic cancer drug

Galera earns key FDA designation for pancreatic cancer drug

Clinical Trials Arena

Galera Therapeutics

pancreatic cancer

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