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FDA+ channel feed
Pandemic wait is over: FDA begins transition to in-person meetings in March
3 years ago
Covid public health emergencies to end in May, but FDA's EUA authority will continue
3 years ago
Pharma
Coronavirus
Oracle executive Troy Tazbaz named new FDA director of digital health
3 years ago
People
Pharma
FDA approves Italy-based pharma's oral SERD for some breast cancer patients
3 years ago
Novavax gets ready to take another shot at Covid vaccine market with next season plans
3 years ago
Pharma
Post-hoc analysis: EMA's CHMP rejects Ipsen's potential drug for rare genetic disease
3 years ago
Pharma
FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting
3 years ago
R&D
Pharma
Four years in, Sana gets first FDA go-ahead to bring cancer treatment into the clinic
3 years ago
Cell/Gene Tx
FDA advisory committee votes unanimously in favor of bivalent Covid shots replacing primary series
3 years ago
Pharma
FDA reports initial 'no signal' for stroke risk with Pfizer boosters, launches concomitant flu shot study
3 years ago
Pharma
FDA cuts off use for AstraZeneca’s Covid-19 therapy Evusheld
3 years ago
Pharma
Coronavirus
FDA takes next step in Torrent Pharmaceuticals' troubled India plant saga, issues OAI
3 years ago
Pharma
Manufacturing
FDA sends warning letter to community hospital review board over research concerns
3 years ago
Pharma
EMA changes orphan designation policy for certain eye drugs to expand access
3 years ago
Pharma
ODAC to debate Roche's Polivy in first-line DLBCL following 2019 accelerated approval
3 years ago
Novartis petitions Supreme Court in effort to 'vigorously defend' Gilenya patent
3 years ago
Pharma
Law
Advocacy group accuses Novo Nordisk of violating FDA's 'fair balance' advertising rules
3 years ago
Pharma
Marketing
FDA lays the finishing touches on its plan to pull Makena
3 years ago
Pharma
On orphan drug exclusivity, FDA decides to go its own way after court loss
3 years ago
FDA will consult outside advisors on whether Biogen’s ALS drug can be approved on a biomarker
3 years ago
FDA hopes to simplify and standardize Covid shots without making them interchangeable
3 years ago
Coronavirus
Next-gen mpox treatments: FDA calls for diverse, randomized controlled trials
3 years ago
'Blue Brain Boost': FDA blocks Colorado couple from importing and reselling drugs from China
3 years ago
FDA lifts clinical hold on Astellas’ Pompe gene therapy
3 years ago
Cell/Gene Tx
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