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FDA+ channel feed
Opinion: Adolescents can wait. The US needs to start donating Covid-19 vaccines to needy countries now.
5 years ago
Opinion
RWE upstart maps a new global plan as investors pour in the latest mega-round
5 years ago
Financing
Biden administration signals that FDA may allow abortion pill access via mail even after the pandemic
5 years ago
EMA safety committee seeks more info on heart inflammation following Pfizer Covid-19 vaccine
5 years ago
Coronavirus
Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug
5 years ago
Pharma
Recall report: Acella pulls thyroid tablets after a raft of side effect reports; mislabeling causes Pfizer's Hospira to yank 2 lots of anesthetics
5 years ago
Manufacturing
Biden administration backs a polarizing proposal to waive IP for all Covid-19 vaccines
5 years ago
Pharma
Manufacturing
FDA extends research agreement with MIT-licensed organ-on-chip systems
5 years ago
Pharma
In quest to meet user fee goals, FDA’s performance continues downward trend
5 years ago
Pharma
Opinion: Waiving Covid-19 vaccine IP could save lives, but where is the manufacturing capacity?
5 years ago
Opinion
ChemoCentryx plunges as FDA raises questions about rare disease drug ahead of adcomm
5 years ago
Pharma
Sigma-Aldrich hit with $9M fine for misleading info during Merck KGaA merger
5 years ago
Deals
ICH plots major overhaul of good clinical practice guideline
5 years ago
R&D
AstraZeneca's big CKD promises come to fruition as Farxiga wins approval in patients regardless of diabetes status
5 years ago
Biogen won’t explain why FDA slapped down their bid for new Tysabri formulation
5 years ago
Pharma
Bristol Myers' Opdivo scores priority review in common bladder cancer, marking latest win in PD-1 battle with Keytruda
5 years ago
Pharma
More info on drug review timelines? HHS and FDA pull Trump HHS’ last-minute pledge
5 years ago
Pharma
FDA hits Leo Pharma with a CRL for what the biotech says are questions about the 'device component' of eczema candidate
5 years ago
Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals
5 years ago
R&D
Pharma
FDA pandemic delays strike again with Israeli microcap the latest to receive a CRL based on inspection setbacks
5 years ago
ODAC votes to keep Keytruda and Tecentriq accelerated approvals in bladder cancer
5 years ago
Pharma
FDA warns Acceleron of possible fines for not posting results from failed trial
5 years ago
With Amy Abernethy out, Vid Desai takes over as FDA’s acting CIO
5 years ago
Opinion: Meaningful drug pricing reforms are headed nowhere fast
5 years ago
Pharma
Opinion
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