FDA

Pfizer's Biohaven bet pays off again as migraine nasal spray wins approval
BioSpace
Fri, 03/10/23 - 11:32 am
Pfizer
Biohaven
FDA
migraines
nasal spray
zavegepant
Zavzpret
FDA adcomm votes 11-2 to expand Roche's Polivy label in DLBCL
Endpoints
Thu, 03/9/23 - 10:21 pm
Roche
FDA
Polivy
DLBCL
Amphastar Pharmaceuticals Receives FDA Approval for Naloxone Hydrochloride Nasal Spray 4mg
Yahoo Finance
Thu, 03/9/23 - 10:20 pm
Amphastar
FDA
intranasal naloxone
opioid overdose
Akorn's downfall amplifies shortage of asthma med albuterol, FDA warns
Fierce Pharma
Thu, 03/9/23 - 10:18 pm
Akorn
drug shortages
albuterol
FDA
FDA seeks 10% boost in Biden’s FY 2024 budget
RAPS.org
Thu, 03/9/23 - 10:15 pm
FDA
Joe Biden
FDA placed hold on Fulcrum's sickle cell therapy over hematological malignancy concerns
Fierce Biotech
Thu, 03/9/23 - 11:43 am
FDA
Fulcrum Therapeutics
sickle cell therapy
FDX-6058
clinical hold
FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt
Stat
Wed, 03/8/23 - 09:55 pm
FDA
diagnostics
COVID-19
Flu
Lucira
FDA says no adcomm planned for Biogen, Sage's depression drug
Seeking Alpha
Wed, 03/8/23 - 09:47 pm
Biogen
SAGE Therapeutics
FDA
zuranolone
major depressive disorder
postpartum depression
Lucira Gets FDA Authorization for First OTC At-Home Test for COVID-19 and Flu
Xtalks
Wed, 03/8/23 - 09:49 am
Lucira
diagnostics
FDA
COVID-19
Flu
Ionis announces FDA acceptance of New Drug Application for eplontersen for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy
PR Newswire
Wed, 03/8/23 - 09:47 am
Ionis Pharmaceuticals
FDA
eplontersen
hATTR-pn
BioMarin Answers BridgeBio's Challenge with sNDA for Achondroplasia
BioSpace
Wed, 03/8/23 - 09:42 am
Biomarin
BridgeBio
achondroplasia
FDA
Voxzogo
Pfizer (PFE) or GSK: Who Will Get the First FDA Nod for RSV Jab?
Yahoo/Zacks.com
Wed, 03/8/23 - 09:30 am
GSK
Pfizer
FDA
vaccines
RSV
FDA delays review of BioMarin's hemophilia gene therapy after data update
Endpoints
Tue, 03/7/23 - 11:16 am
Biomarin
gene therapy
hemophilia A
FDA
valrox
FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency
BioPharma Dive
Mon, 03/6/23 - 11:37 pm
FDA
Makena
preterm birth
Covis Pharma
Sarepta: FDA finds ‘no significant safety issues of concern’ with DMD gene therapy
Biopharma Reporter
Mon, 03/6/23 - 11:29 pm
Sarepta Therapeutics
DMD
Duchenne Muscular Dystrophy
gene therapy
FDA
Abbott Scores a 'Long-Awaited Win' in Diabetes
Medical Devices and Diagnostics Industry
Mon, 03/6/23 - 11:25 pm
Abbott Labs
diabetes
Medtech
Freestyle Libre 2
FreeStyle Libre 3
FDA
Researchers call on FDA to get tough on accelerated approval labeling
RAPS.org
Mon, 03/6/23 - 11:19 pm
FDA
regulatory
accelerated approval
FDA sets July decision date for full approval of Leqembi
BioSpace
Mon, 03/6/23 - 12:11 pm
Eisai
Biogen
Alzheimer's disease
Leqembi
FDA
lecanemab
Woodcock: Pending ORA reorg will “modify things significantly” for all FDA regulated products
RAPS.org
Sun, 03/5/23 - 03:13 pm
FDA
ORA
regulatory
Janet Woodcock
FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs
BioPharma Dive
Sun, 03/5/23 - 03:08 pm
Merck
AstraZeneca
Lynparza
FDA
PARP inhibitors

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