FDA

As FDA resumes foreign inspections, GAO recommends revamping the program
RAPS.org
Tue, 02/8/22 - 11:52 pm
GAO
FDA
regulatory
foreign inspections
ADCs in the pipeline: FDA spells out clinical pharmacology musts for sponsors
Endpoints
Mon, 02/7/22 - 11:21 pm
FDA
regulatory
antibody-drug conjugate
Clinical Pharmacology
FDA approves Sanofi's monoclonal antibody treatment for CAD
Biopharma Reporter
Mon, 02/7/22 - 10:29 am
Sanofi
cold agglutinin disease
FDA
monoclonal antibodies
Enjaymo
Will a New FDA-Approved COVID Pill Propel This Healthcare Company's Stock?
Motley Fool
Sat, 02/5/22 - 12:04 pm
FDA
Merck
COVID-19
molnupiravir
Must-pass user fee deals: Biopharma companies fund more than 80% of FDA's review staff, CDER head tells Congress
Endpoints
Thu, 02/3/22 - 11:39 pm
FDA
user fees
regulatory
How Concerning Is Pfizer and Opko's Latest FDA Rejection?
Motley Fool
Thu, 02/3/22 - 11:11 pm
Pfizer
OPKO Health
FDA
somatrogon
Califf pledges not to use ‘revolving door’ between FDA and industry
Pharmaforum
Thu, 02/3/22 - 10:33 am
Robert Califf
FDA
regulatory
AbbVie's blockbuster eye drug Restasis under threat as FDA approves Viatris' copycat
Fierce Pharma
Wed, 02/2/22 - 11:50 pm
AbbVie
earnings
Restasis
FDA
generics
ViiV Healthcare gets FDA nod for two-month dosing of Cabenuva to treat HIV
Pharmaceutical Business Review
Wed, 02/2/22 - 10:57 am
ViiV Healthcare
FDA
HIV
Cabenuva
Doctor groups urge Biden administration to disclose costs of federally funded clinical trials
Fierce Biotech
Tue, 02/1/22 - 11:33 pm
Joe Biden
physicians
clinical trials
BARDA
FDA
HHS
Novavax finally submits its COVID-19 vaccine to the FDA. Is it too late?
Fierce Pharma
Mon, 01/31/22 - 11:59 pm
Novavax
COVID-19
vaccines
FDA
Emergency Use Authorization
In pledging to vote for Rob Califf, Elizabeth Warren takes a swing at the FDA-industry revolving door
Endpoints
Mon, 01/31/22 - 11:45 pm
FDA
Robert Califf
Elizabeth Warren
And then there were 2: FDA gives full approval to Moderna’s Covid-19 vaccine
Stat
Mon, 01/31/22 - 12:20 pm
Moderna Therapeutics
COVID-19
vaccines
Spikevax
FDA
Roche grabs FDA okay for would-be blockbuster eye drug faricimab
Pharmaforum
Mon, 01/31/22 - 10:51 am
Roche
faricimab
Eylea
Bayer
Regeneron
FDA
TG slips out a nasty surprise for investors
EP Vantage
Mon, 01/31/22 - 10:40 am
TG Therapeutics
FDA
CLL
clinical hold
Roche looks to compete against a blockbuster with its newly approved vision drug
Stat
Sun, 01/30/22 - 11:53 am
Roche
FDA
bispecific antibodies
Regeneron
Vabysmo
wet age-related macular degeneration
diabetic macular edema
Nevro Takes Medtronic to Task Over Diabetic Neuropathy Data
Medical Devices and Diagnostics Industry
Sun, 01/30/22 - 11:50 am
devices
Nevro
Medtronic
FDA
Spinal Cord Stimulation
diabetic neuropathy
Eli Lilly, Incyte axe Olumiant in lupus amid eczema stalemate at FDA
Fierce Pharma
Fri, 01/28/22 - 11:47 am
Eli Lilly
Incyte
olumiant
FDA
lupus
eczema
‘There’s no free lunch with drugs’: Janet Woodcock talks Covid monoclonal antibodies and pediatric vaccines
Stat
Fri, 01/28/22 - 10:16 am
FDA
monoclonal antibodies
Janet Woodcock
vaccines
COVID-19
Cortexyme to shift focus after FDA places hold on experimental Alzheimer's drug
BioPharma Dive
Thu, 01/27/22 - 11:44 pm
Cortexyme
FDA
Alzheimer's disease

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