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about the author
Lia DeGroot
ldegroot@endpointsnews.com
author articles
AstraZeneca, Boehringer Ingelheim, GSK defend patent listings as Klobuchar amps up pressure
Last year
Pharma
FDA+
The Supreme Court could overturn the Chevron doctrine. Here’s how that could hurt the FDA
Last year
Pharma
FDA+
FDA+ roundup: Sen. Tillis goes after Biden administration for supporting march-in rights
Last year
Pharma
FDA+
Oncology drugs lead 2023 new medicines in Europe — EMA report
Last year
Pharma
FDA+
PhRMA, Eli Lilly, other drug companies push back on FDA's draft guidance about communicating off-label use
Last year
Pharma
FDA+
FDA determines GLP-1s not linked to suicidal thoughts or actions in preliminary review
Last year
Pharma
FDA+
FDA develops pilot to harmonize international gene therapy regulations
Last year
Pharma
Cell/Gene Tx
How generic drug sponsors can ask FDA to reconsider applications: new draft guidance explains
Last year
Pharma
FDA+
FDA chief taps Elizabeth Jungman as new chief of staff, starting later this month
Last year
Pharma
FDA+
As Congress debates orphan reforms, new analysis finds 65% of orphan drugs approved for a single rare disease
Last year
Pharma
FDA+
Senate health committee investigates inhaler manufacturers for high prices
Last year
Pharma
FDA+
Semaglutide associated with lower risk of suicidal ideations compared to non-GLP-1 drugs: NIH-funded study
Last year
Pharma
House Republicans call on FDA to hand over info on internal scientific disagreements
Last year
Pharma
FDA+
Biden administration to use Defense Production Act to tackle drug shortages
Last year
Pharma
FDA+
Beyfortus approved in China to protect infants from RSV; Illumina investor files class action suit
Last year
Pharma
Longboard stock soars on heels of positive topline data for seizure medication
Last year
R&D
Pharma
FDA seizes thousands of counterfeit Ozempic units, warns consumers not to use
Last year
Pharma
FDA+
IRA likely to lead to higher drug list prices and bigger rebates, Congressional Budget Office predicts
Last year
Pharma
FDA+
FDA findings at Moderna's Massachusetts facility don't reflect quality, safety concerns, company says
Last year
Pharma
FDA+
FDA to set up new Office of the Chief Medical Officer as part of agency reshuffling
Last year
Pharma
FDA+
FDA encourages collaboration between monoclonal antibody sponsors to keep pace with emerging Covid variants
Last year
R&D
Pharma
Merck clinches priority review for pneumococcal vaccine, raising stakes for Pfizer
Last year
Pharma
FDA+
FDA finalizes opioid safety labeling changes
Last year
Pharma
FDA+
Europe lines up first CRISPR therapy approval
Last year
Pharma
FDA+
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