FDA+ channel feed – Endpoints News

FDA+ channel feed

Bipartisan group of lawmakers seeks to reign in pharma patent thickets with new bill

Last year

Updated: FDA’s safety review on CAR-Ts culminates in new boxed warnings of secondary cancer

Last year

Autolus eyes November for potential US approval of Tecartus rival

Last year

For clinician-administered drugs, researchers find no association between price increases and OOP cost increases

Last year

FDA highlights priority review vouchers redeemed as reauthorization lingers in Congress

Last year

Novartis' TV ad for breast cancer drug Kisqali draws untitled letter from FDA

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J&J wins full approval for bladder cancer drug

Last year

DeSantis, Johnson raise flags around Covid boosters as FDA maintains that they're safe and effective

Last year

AstraZeneca's rare blood disorder pill approved in Japan

Last year

AstraZeneca, Boehringer Ingelheim, GSK defend patent listings as Klobuchar amps up pressure

Last year

The Supreme Court could overturn the Chevron doctrine. Here’s how that could hurt the FDA

Last year

Satsuma's nasal migraine candidate rejected by FDA over CMC issues

Last year

FDA+ roundup: Sen. Tillis goes after Biden administration for supporting march-in rights

Last year

Oncology drugs lead 2023 new medicines in Europe — EMA report

Last year

A decade after its first FDA approval, Takeda expands label of HyQvia to include rare autoimmune disorder

Last year

FDA approves Vertex and CRISPR's Casgevy as first CRISPR-edited therapy for beta-thalassemia

Last year

PhRMA, Eli Lilly, other drug companies push back on FDA's draft guidance about communicating off-label use

Last year

FDA determines GLP-1s not linked to suicidal thoughts or actions in preliminary review

Last year

FDA develops pilot to harmonize international gene therapy regulations

Last year

How generic drug sponsors can ask FDA to reconsider applications: new draft guidance explains

Last year

FDA commissioner says agency cannot be the only regulator of AI in digital health

Last year

FDA's CBER chief hints at expanding Sarepta's gene therapy label, sends stock up 25%

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FDA chief taps Elizabeth Jungman as new chief of staff, starting later this month

Last year

As Congress debates orphan reforms, new analysis finds 65% of orphan drugs approved for a single rare disease

Last year

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