FDA

FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment
FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment
RAPS.org
Teva Pharmaceutical
FDA
generics
Naloxone
Narcan
opioid overdose
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Consumer watchdog petitions FDA for black box warning on Amgen's Prolia
Consumer watchdog petitions FDA for black box warning on Amgen's Prolia
Fierce Pharma
FDA
osteoporosis
Amgen
Prolia
spinal fractures
Public Citizen
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Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH
Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH
RAPS.org
FDA
CDER
CBER
CDRH
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Akorn Inc. Scores Two Generic Approvals from the FDA
Akorn Inc. Scores Two Generic Approvals from the FDA
BioSpace
Akorn
FDA
generics
Flonase
GSK
Lotemax
Bausch + Lomb
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CBER Director Notes FY 2018 Accomplishments, Including Approval of Two Gene Therapies
CBER Director Notes FY 2018 Accomplishments, Including Approval of Two Gene Therapies
BioSpace
FDA
CBER
gene therapy
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FDA draft guidance suggests comparing bispecifics to monospecific antibodies
FDA draft guidance suggests comparing bispecifics to monospecific antibodies
BioCentury
FDA
bispecific antibodies
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Genfit bags FDA breakthrough tag on route to phase 3 in PBC
Genfit bags FDA breakthrough tag on route to phase 3 in PBC
Fierce Biotech
Genfit
FDA
primary biliary cholangitis
elafibranor
clinical trials
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COPD space about to have another drug
COPD space about to have another drug
Bizjournals
Circassia
COPD
Duaklir Pressair
FDA
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The king is dead, long live the king: Sharpless vows to continue Gottlieb era at FDA
The king is dead, long live the king: Sharpless vows to continue Gottlieb era at FDA
Fierce Biotech
FDA
Scott Gottlieb
Ned Sharpless
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With FDA decision near, Novartis bolsters SMA gene therapy case
With FDA decision near, Novartis bolsters SMA gene therapy case
Biopharma Dive
Novartis
FDA
Zolgensma
spinal muscular atrophy
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Mesoblast poised to file cell therapy for GVHD in US
Mesoblast poised to file cell therapy for GVHD in US
Pharmaforum
Mesoblast
stem cells
graft vs host disease
FDA
remestemcel-L
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FDA halts sales of pelvic mesh tied to injuries in women
FDA halts sales of pelvic mesh tied to injuries in women
Stat
pelvic mesh
FDA
devices
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FDA to Launch New Website Next Week
FDA to Launch New Website Next Week
RAPS.org
FDA
Ned Sharpless
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Gottlieb, biosimilars companies and consultants reject price control proposal
Gottlieb, biosimilars companies and consultants reject price control proposal
BioCentury
biosimilars
drug pricing
FDA
Scott Gottlieb
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FDA accepts BLA for Novartis' AMD therapy
FDA accepts BLA for Novartis' AMD therapy
BioCentury
Novartis
FDA
wet age-related macular degeneration
brolucizumab
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Dr Reddy's acquires a portfolio of 42 ANDAs in US
Dr Reddy's acquires a portfolio of 42 ANDAs in US
Economic Times, India
Dr Reddy's
FDA
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Adverum Bio offers a late notification about FDA hold on lead gene therapy for wet AMD
Adverum Bio offers a late notification about FDA hold on lead gene therapy for wet AMD
Endpoints
Adverum Biotechnologies
CMC
gene therapy
wet age-related macular degeneration
FDA
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FDA approves PureTech’s obesity device Plenity
FDA approves PureTech’s obesity device Plenity
Pharmaforum
FDA
PureTech Health
devices
obesity
Plenity
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J&J's Balversa gets accelerated approval for bladder cancer
J&J's Balversa gets accelerated approval for bladder cancer
BioCentury
JNJ
Janssen
Balversa
bladder cancer
FDA
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Alnylam's givosiran reduces mean porphyria attacks by 74% in Phase III
Alnylam's givosiran reduces mean porphyria attacks by 74% in Phase III
BioCentury
Alnylam
FDA
givosiran
acute hepatic porphyria
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