FDA

FDA adcomm votes 12-1 against Levo Therapeutics' nasal spray for a disorder that causes insatiable hunger
Endpoints
Fri, 11/5/21 - 09:45 am
FDA
Levo Therapeutics
Prader-Willi Syndrome
Why did FDA ask Amgen to add low-dose trial of Lumakras?
Korea Biomed
Wed, 11/3/21 - 10:47 am
FDA
Amgen
clinical trials
Lumakras
oncology
cancer
Amylyx asks FDA to approve ALS drug, while also preparing late-stage study
BioPharma Dive
Tue, 11/2/21 - 10:58 am
Amylyx Pharmaceuticals
AMX-0035
FDA
ALS
What to expect from Tuesday’s CDC meeting about BioNTech and Pfizer’s COVID-19 shots for young children
Marketwatch
Tue, 11/2/21 - 10:52 am
CDC
Pfizer
BioNTech
vaccines
COVID-19
pediatric
FDA
FDA pushes back decision on J&J, Legend's BCMA CAR-T
Endpoints
Tue, 11/2/21 - 10:42 am
JNJ
Legend Biotech
FDA
CAR-T
cilta-cel
AbbVie claims first FDA okay for presbyopia drug therapy
Pharmaforum
Mon, 11/1/21 - 10:59 am
AbbVie
FDA
presbyopia
AGN-190584
Even AbbVie CEO can't confirm Rinvoq's sales as FDA mulls JAK label
Fierce Pharma
Mon, 11/1/21 - 10:55 am
AbbVie
Pharma CEOs
Rick Gonzalez
Rinvoq
FDA
Moderna Dives As FDA Delays Covid Vaccine In Teens To Investigate 'Rare' Side Effect
Investors Business Daily
Mon, 11/1/21 - 10:46 am
Moderna Therapeutics
FDA
adolescents
myocarditis
vaccines
COVID-19
FDA Approves Scemblix for Pretreated CML in the Chronic Phase
Cure Today
Sat, 10/30/21 - 10:46 pm
Novartis
Scemblix
FDA
CML
FDA clears Pfizer's Covid-19 vaccine for children ages 5-11
Endpoints
Sat, 10/30/21 - 11:58 am
Pfizer
BioNTech
vaccines
COVID-19
FDA
Emergency Use Authorization
pediatric
FDA restricts breast implant sales, cites Allergan and J&J for inadequate postapproval progress
Medtech Dive
Fri, 10/29/21 - 10:39 am
FDA
breast implants
devices
JNJ
Allergan
Medtech
Go or go go? J&J’s cell therapy heads to the FDA
EP Vantage
Fri, 10/29/21 - 10:33 am
JNJ
cilta-cel
Multiple Myeloma
FDA
Biomarin
Merck
molnupiravir
FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
FDA
Wed, 10/27/21 - 11:49 pm
Bespoke Gene Therapy Consortium
NIH
FDA
gene therapy
Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer
Xtalks
Wed, 10/27/21 - 10:58 am
Genentech
Roche
ocular implant delivery
macular degeneration
FDA
wet age-related macular degeneration
FDA advisory panel recommends Pfizer Covid-19 vaccine be authorized for children
Stat
Tue, 10/26/21 - 11:56 pm
FDA
Pfizer
BioNTech
vaccines
COVID-19
pediatric
FDA Advisory Panel Red Lights Integra's Breast Reconstruction Mesh
Medical Devices and Diagnostics Industry
Tue, 10/26/21 - 11:47 pm
FDA
Integra Life Sciences
SurgiMend
breast reconstruction
devices
Eli Lilly kick-starts speedy FDA review for Alzheimer's hopeful donanemab—and a one-on-one test against Aduhelm
Fierce Biotech
Tue, 10/26/21 - 10:50 am
Eli Lilly
Alzheimer's disease
FDA
donanemab
Biogen
Aduhelm
zagotenemab
Tracking the FDA's meeting on Pfizer's vaccine for kids
BioPharma Dive
Tue, 10/26/21 - 10:38 am
FDA
regulatory
Pfizer
BioNTech
vaccines
COVID-19
pediatric
FDA shuts down anti-vax lawyer's petition to end Moderna and J&J EUAs
Endpoints
Tue, 10/26/21 - 10:33 am
attorneys
vaccines
COVID-19
FDA
Moderna Therapeutics
JNJ
FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule
FDA Law Blog
Mon, 10/25/21 - 11:58 pm
FDA
regulatory
de novo pathway
devices

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