FDA

Pfizer wants to help the FDA with its new, court-mandated $4-5M FOIA release on the company's Covid-19 vaccine data
Endpoints
Thu, 01/27/22 - 11:02 am
Pfizer
FDA
Freedom of Information Act
vaccines
COVID-19
Novo Nordisk's Wegovy, hamstrung by Catalent FDA write-up, could correct course by mid-2022: analysts
Fierce Pharma
Thu, 01/27/22 - 10:47 am
Novo Nordisk
Catalent
Wegovy
obesity
FDA
Aurobindo warned for lax investigations, repeat GMP violations
RAPS.org
Thu, 01/27/22 - 10:46 am
regulatory
FDA
Aurobindo
drug manufacturing
Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47
Fierce Biotech
Wed, 01/26/22 - 11:12 am
Gilead Sciences
magrolimab
anti-CD47
FDA
clinical trials
oncology
clinical hold
Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit
Fierce Biotech
Wed, 01/26/22 - 10:57 am
Incyte
FDA
parsaclisib
Immunocore soars 17% as FDA approves Kimmtrak for uveal melanoma
Seeking Alpha
Wed, 01/26/22 - 10:53 am
Immunocore
Kimmtrak
FDA
uveal melanoma
Go or no go? PDUFA resolutions eyed for J&J and Amryt
EP Vantage
Wed, 01/26/22 - 10:40 am
FDA
JNJ
Legend Biotech
ciltacabtagene autoleucel
Amryt
Oleogel-S10
Roche's aim to widen Evrysdi's label nabs speedy FDA review in young spinal muscular atrophy patients
Fierce Pharma
Tue, 01/25/22 - 10:54 am
Roche
Evrysdi
risdiplam
FDA
spinal muscular atrophy
Trulicity Instagram post draws OPDP’s first untitled letter of 2022
RAPS.org
Mon, 01/24/22 - 11:37 pm
Eli Lilly
Trulicity
OPDP
FDA
social media
AbbVie's (ABBV) Skyrizi Gets FDA Nod for Psoriatic Arthritis
Yahoo/Zacks.com
Mon, 01/24/22 - 11:30 pm
AbbVie
Skyrizi
FDA
psoriatic arthritis
Merck: FDA Rejects Gefapixant Application, Requests More Data
Marketwatch
Mon, 01/24/22 - 10:22 am
Merck
chronic cough
FDA
gefapixant
1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial
Fierce Biotech
Mon, 01/24/22 - 10:19 am
Viking Therapeutics
clinical trials
FDA
VK0214
metabolic disorders
Months after pulling only drug from US, Oncopeptides takes back withdrawal request — but stays mum on why
Endpoints
Mon, 01/24/22 - 10:16 am
Oncopeptides
FDA
Pepaxto
Multiple Myeloma
FDA's domestic inspection hold will continue until February
Endpoints
Mon, 01/24/22 - 10:13 am
FDA
regulatory
regulatory inspections
What This FDA News Could Mean for AbbVie's Stock
Motley Fool
Mon, 01/24/22 - 10:10 am
AbbVie
Rinvoq
FDA
Pfizer’s growth hormone deficiency drug comes up short at the FDA
MedCity News
Mon, 01/24/22 - 09:59 am
Pfizer
FDA
human growth hormone
OPKO Health
somatrogon
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
RAPS.org
Fri, 01/21/22 - 11:01 am
FDA
regulatory
clinical trials
clinical trial diversity
generics
Biliary tract cancer drug granted orphan drug designation in US
Pharmaforum
Fri, 01/21/22 - 10:56 am
Senhwa
biliary tract cancer
silmitasertib
FDA
orphan drugs
Device approval times lengthen
EP Vantage
Fri, 01/21/22 - 10:36 am
FDA
devices
device approvals
Califf on accelerated approvals: Companies need to do more work before FDA says OK
Endpoints
Thu, 01/20/22 - 11:05 am
FDA
Robert Califf
accelerated approvals

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