FDA

Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL
Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL
BioCentury
AbbVie
FDA
priority review
Imbruvica
Gazyva
CLL
SLL
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AstraZeneca, Merck’s Lynparza gets FDA ODD for pancreatic cancer
AstraZeneca, Merck’s Lynparza gets FDA ODD for pancreatic cancer
Pharmaceutical Business Review
AstraZeneca
Merck
Lynparza
FDA
pancreatic cancer
orphan drug
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FDA’s OPDP Warns MannKind for Facebook Post
FDA’s OPDP Warns MannKind for Facebook Post
RAPS.org
Afrezza
warning letter
FDA
OPDP
Facebook
social media
diabetes
MannKind
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FDA mandates pediatric trials for 200 cancer targets
FDA mandates pediatric trials for 200 cancer targets
BioCentury
FDA
pediatric
clinical trials
oncology
cancer
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FDA approves Pfizer's drug for advanced breast cancer
FDA approves Pfizer's drug for advanced breast cancer
Reuters
FDA
Pfizer
PARP inhibitors
talazoparib
breast cancer
BRCA-mutant breast cancer
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FDA approves five-year hormonal contraceptive
FDA approves five-year hormonal contraceptive
Drug Delivery Business News
Allergan
Medicines360
FDA
contraceptives
Liletta
IUD
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3 Biotechs Awaiting FDA Approval Decisions
3 Biotechs Awaiting FDA Approval Decisions
Motley Fool
FDA
TherapeuticsMD
TX-001HR
AcelRx
Dsuvia
Loxo Oncology
larotrectinib
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Pharma Failures Actually Advance Medicine
Pharma Failures Actually Advance Medicine
Forbes
FDA
R&D
drug development
Pfizer
Torcetrapib
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Kala seeks FDA nod for dry eye disease drug
Kala seeks FDA nod for dry eye disease drug
Drug Delivery Business News
Kala Pharmaceuticals
FDA
KPI-121
dry eye disease
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Real threat to Opdivo’s small-cell chances will come from elsewhere
Real threat to Opdivo’s small-cell chances will come from elsewhere
EP Vantage
Bristol-Myers Squibb
Opdivo
Small-Cell Lung Cancer
FDA
Tecentriq
Roche
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Alnylam shares drop 1.8% on new FDA approval strategy for rare disease drug
Alnylam shares drop 1.8% on new FDA approval strategy for rare disease drug
Marketwatch
Alnylam
FDA
givosiran
acute hepatic porphyria
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FDA panel votes in favor of AcelRx's pain candidate
FDA panel votes in favor of AcelRx's pain candidate
BioCentury
Dsuvia
ARX-04
FDA
AcelRx
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Hit by FDA red flags, cited for misleading investors and battered by a thumbs-down from experts, it’s been one terrible week for Trevena
Hit by FDA red flags, cited for misleading investors and battered by a thumbs-down from experts, it’s been one terrible week for Trevena
Endpoints
Travena
FDA
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FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices
FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices
RAPS.org
devices
Medtronic
FDA
cybersecurity
CIED
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FDA sets record for number of generic drug approvals again
FDA sets record for number of generic drug approvals again
Endpoints
FDA
generics
drug approvals
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Advisory panel narrowly rejects oliceridine for acute pain
Advisory panel narrowly rejects oliceridine for acute pain
BioCentury
FDA
advisory panels
Trevena
TRV130
severe pain
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Mylan Pharmaceuticals Pledges to Resolve FDA Citations Over Quality Control Failures
Mylan Pharmaceuticals Pledges to Resolve FDA Citations Over Quality Control Failures
RAPS.org
Mylan Labs
drug manufacturing
FDA
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Synspira's Cystic Fibrosis Treatment Receives Orpan Drug Designation
Synspira's Cystic Fibrosis Treatment Receives Orpan Drug Designation
CP Wire
Synspira
FDA
SNSP113
cystic fibrosis
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Pfizer, J&J, Amgen and Roche Start a Bare-Knuckle Brawl Over Biosimilars
Pfizer, J&J, Amgen and Roche Start a Bare-Knuckle Brawl Over Biosimilars
BioSpace
Pfizer
Amgen
Roche
FDA
social media
biosimilars
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Roche and Novartis Strengthen Their Presence in the MS Market
Roche and Novartis Strengthen Their Presence in the MS Market
BioSpace
Genentech
Roche
Ocrevus
Novartis
siponimod
FDA
MS
multiple sclerosis
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