FDA

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
Flag link:
FDA to Launch New Website Next Week
FDA to Launch New Website Next Week
RAPS.org
FDA
Ned Sharpless
Flag link:
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
Flag link:
FDA accepts BLA for Novartis' AMD therapy
FDA accepts BLA for Novartis' AMD therapy
BioCentury
Novartis
FDA
wet age-related macular degeneration
brolucizumab
Flag link:
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
Flag link:
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
Flag link:
FDA approves PureTech’s obesity device Plenity
FDA approves PureTech’s obesity device Plenity
Pharmaforum
FDA
PureTech Health
devices
obesity
Plenity
Flag link:
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
Flag link:
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
Flag link:
FDA expands Keytruda approval for first-line NSCLC treatment
FDA expands Keytruda approval for first-line NSCLC treatment
Pharmaforum
Merck
Keytruda
FDA
non-small cell lung cancer
Flag link:
FDA tells Sprout Pharma, like it or not the black box on Addyi stays, but we will dilute the warning
FDA tells Sprout Pharma, like it or not the black box on Addyi stays, but we will dilute the warning
Endpoints
FDA
Sprout Pharmaceuticals
Addyi
female sexual dysfunction
Flag link:
Wockhardt receives US FDA approval for cancer drug
Wockhardt receives US FDA approval for cancer drug
Pharmaceutical Business Review
Wockhardt
decitabine
FDA
generics
Otsuka
Dacogen
myelodysplastic syndromes
Flag link:
Helius Medical shares tank on FDA denial
Helius Medical shares tank on FDA denial
Mass Device
Helius
devices
neuromodulation
FDA
Flag link:
Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation
Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation
RAPS.org
Braeburn Pharmaceuticals
citizen petitions
FDA
orphan drug
Sublocade
Indivior
Flag link:
FDA approves Evenity for osteoporosis
FDA approves Evenity for osteoporosis
BioCentury
FDA
Evenity
romosozumab
Amgen
UCB Pharma
osteoporosis
Flag link:
GSK wins U.S. nod for two-drug HIV combination
GSK wins U.S. nod for two-drug HIV combination
Yahoo/Reuters
GSK
FDA
HIV
Dovato
Flag link:
FDA snubs Zogenix's anti-seizure drug, not happy with some sloppy, inadequate R&D work
FDA snubs Zogenix's anti-seizure drug, not happy with some sloppy, inadequate R&D work
Endpoints
Zogenix
Dravet syndrome
FDA
refuse to file letters
Flag link:
FDA's Pazdur encourages Chinese companies to bring low-cost PD-1 drugs to U.S. market
FDA's Pazdur encourages Chinese companies to bring low-cost PD-1 drugs to U.S. market
BioCentury
Richard Pazdur
FDA
China
anti-PD-L1
Flag link:
Protesters’ goodbye for Scott Gottlieb: a supersized heroin spoon and claims FDA did too little on opioids
Protesters’ goodbye for Scott Gottlieb: a supersized heroin spoon and claims FDA did too little on opioids
Stat
activists
FDA
Scott Gottlieb
opioids
opioid crisis
Flag link:
Industry and Advocacy Groups Urge FDA to Allow More Real-World Data for Rare Disease Trials
Industry and Advocacy Groups Urge FDA to Allow More Real-World Data for Rare Disease Trials
BioSpace
FDA
Rare Diseases
real world data
Flag link:

Pages