FDA

FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors
BioSpace
Wed, 04/20/22 - 11:19 pm
FDA
regulatory
cancer
PI3k inhibitor
FDA lawyer digs in her heels as Makena accelerated approval withdrawal saga drags on
Endpoints
Wed, 04/20/22 - 10:54 am
Covis Pharma
Makena
FDA
preterm birth
Teva receives CRL for reformulated schizophrenia drug developed with French biotech
Endpoints
Wed, 04/20/22 - 10:48 am
Teva Pharmaceutical
MedinCell
schizophrenia
FDA
complete response letter
Kite’s Maryland CAR T-cell therapy site gets FDA go-ahead
Biopharma Reporter
Wed, 04/20/22 - 10:43 am
Kite Pharma
Gilead Sciences
FDA
CAR-T
drug manufacturing
Yescarta
Axsome and Aytu's Positive Day with the FDA
BioSpace
Tue, 04/19/22 - 11:54 pm
FDA
Axsome Therapeutics
Aytu BioSciences
depression
Vascular Ehlers-Danos Syndrome
Axsome moves 'closer to judgement day' for stalled depression therapy
Fierce Biotech
Tue, 04/19/22 - 11:05 am
Axsome Therapeutics
FDA
depression
AXS-05
FDA starts speedy review of Enhertu in lung cancer
Pharmaforum
Tue, 04/19/22 - 10:54 am
AstraZeneca
Daiichi Sankyo
FDA
non-small cell lung cancer
Enhertu
GSK goes for gold as FDA starts review of daprodustat
Pharmaforum
Tue, 04/19/22 - 10:47 am
GSK
chronic kidney disease
anemia
daprodustat
FDA
As FDA offers breakthrough designation to device makers, patients and providers are left with questions
Stat
Mon, 04/18/22 - 10:51 am
devices
Medtech
FDA
regulatory
breakthrough device
FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
Drugs.com
Mon, 04/18/22 - 10:39 am
Medtech
diagnostics
FDA
COVID-19
InspectIR
Is biopharma getting better at accelerated approval conversions?
EP Vantage
Mon, 04/18/22 - 10:37 am
FDA
CDER
accelerated approvals
regulatory
FDA urges creation of racial, ethnic recruitment plans for clinical trials
Fierce Biotech
Fri, 04/15/22 - 01:46 pm
FDA
clinical trials
clinical trial diversity
drug development
Roche Wakes Up to New Competition as FDA Approves Amneal’s Avastin Biosimilar
BioSpace
Thu, 04/14/22 - 10:57 am
Amneal
FDA
bevacizumab-maly
Genentech
Roche
Avastin
biosimilars
Regeneron's bid for COVID-19 drug's full approval hits snag as FDA extends review
Fierce Pharma
Thu, 04/14/22 - 10:56 am
Regeneron
REGEN-COV
FDA
COVID-19
antibodies
Twist in Protagonist story as FDA seeks to rescind breakthrough nod 'based on observed malignancies'
Fierce Biotech
Thu, 04/14/22 - 10:47 am
Protagnosit Therapeutics
rusfertide
FDA
breakthrough designation
Merck wins breakthrough therapy designation for potential pneumococcal vaccine successor
Endpoints
Thu, 04/14/22 - 10:43 am
Merck
vaccines
pneumococcal disease
V116
FDA
ICER says bluebird bio’s $2.1m gene therapy is cost-effective
Pharmaforum
Thu, 04/14/22 - 10:36 am
Bluebird Bio
ICER
beti-cel
FDA
How McKinsey used its FDA connections to help opioid manufacturers: New congressional report
Endpoints
Wed, 04/13/22 - 05:16 pm
McKinsey
FDA
opioids
opioid crisis
FDA knocks Bausch for misleading promotion of psoriasis drug on Lifetime show
RAPS.org
Tue, 04/12/22 - 08:42 pm
Bausch Health
FDA
OPDP
psoriasis
Doubrii
FDA Sends Curis Cancer Drug into Holding Pattern
BioSpace
Tue, 04/12/22 - 11:01 am
Curis
FDA
emavusertib
clinical trials

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