FDA

Trick, or treat? FDA plans Halloween adcomm for Ipsen’s second chance at rare disease drug
Endpoints
Mon, 08/22/22 - 08:10 pm
Ipsen
FDA
bone disease
palovarotene
FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17
Yahoo Finance
Mon, 08/22/22 - 10:35 am
Novavax
vaccines
COVID-19
FDA
teens
Study: Most accelerated approval indications don’t add high therapeutic value
RAPS.org
Sun, 08/21/22 - 09:45 pm
regulatory
accelerated approvals
Europe
FDA
Eisai inaugurates new US HQ as closely watched FDA Alzheimer's decision draws near
Fierce Pharma
Sun, 08/21/22 - 09:36 pm
Eisai
headquarters
Alzheimer's disease
FDA
Axsome's depression drug enters competitive market after U.S. approval
Reuters
Fri, 08/19/22 - 10:37 am
Axsome Therapeutics
clinical depression
FDA
Auvelity
Bayer gets FDA nod to extend use of popular contraceptive IUD Mirena
Endpoints
Thu, 08/18/22 - 11:16 pm
Bayer
IUD
contraceptives
Mirena
FDA
Astellas' menopause therapy accepted for FDA review 5 months after late-phase study mars record
Fierce Biotech
Thu, 08/18/22 - 12:40 pm
Astellas
menopause
FDA
clinical trials
Asia
fezolinetant
hot flashes
FDA lifts partial hold on Curis' lymphoma study — shares spike
Endpoints
Thu, 08/18/22 - 11:08 am
FDA
Curis
lymphoma
clinical trials
emavusertib
What's behind the FDA's controversial strategy for evaluating new COVID boosters
NPR
Thu, 08/18/22 - 10:38 am
FDA
COVID-19
vaccines. boosters
animal research
Did Sarepta Therapeutics Just Unveil a Breakthrough?
TheStreet.com
Wed, 08/17/22 - 11:37 pm
Sarepta Therapeutics
Duchenne Muscular Dystrophy
FDA
bluebird bio Scores First U.S. Approval for Lentiviral Vector Gene Therapy
BioSpace
Wed, 08/17/22 - 11:34 pm
Bluebird Bio
FDA
gene therapy
beta thalassemia
Zynteglo
beti-cel
Omeros' Hail Mary throw for blood clot med application delayed at FDA
Fierce Biotech
Wed, 08/17/22 - 12:12 pm
Omeros
FDA
narsoplimab
Novavax (NVAX) Seeks FDA Authorization for COVID-19 Booster Dose
Yahoo/Zacks.com
Wed, 08/17/22 - 11:05 am
Novavax
FDA
COVID-19
vaccines
boosters
FDA creates new category of OTC hearing aids, issues PSAP guidance
RAPS.org
Tue, 08/16/22 - 11:57 pm
FDA
Joe Biden
hearing loss
hearing aids
devices
OTC
Medtech
Roche’s Polivy continues its regulatory dance, will head to FDA for a form of blood cancer
Endpoints
Tue, 08/16/22 - 11:17 am
Roche
Polivy
diffuse large B-cell lymphoma
FDA
Emergent nets itself more trouble as it receives a warning letter from the FDA
Endpoints
Tue, 08/16/22 - 10:58 am
Emergent BioSolutions
drug manufacturing
Baltimore
FDA
BrainStorm’s ALS Drug Heads to the FDA with Correction to Phase III Analyses
BioSpace
Mon, 08/15/22 - 10:17 am
BrainStorm Cell Therapeutics
NurOwn
ALS
FDA
clinical trials
BD’s recall of emergency vascular access devices labeled Class I event label by FDA
Medtech Dive
Mon, 08/15/22 - 10:14 am
Medtech
devices
Becton Dickinson
FDA
product recalls
device recalls
This Week at FDA: Amazon warning letter, ANDA amendments, and more
RAPS.org
Sun, 08/14/22 - 10:44 pm
FDA
regulatory
monkeypox
Jynneos
ANDAs
Amazon
devices
Expert: OGD on track to approve more generic drugs in FY2022
RAPS.org
Sun, 08/14/22 - 10:33 pm
FDA
generics
OGD

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