FDA+ channel feed – Endpoints News

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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PhRMA, Eli Lilly, other drug companies push back on FDA's draft guidance about communicating off-label use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How generic drug sponsors can ask FDA to reconsider applications: new draft guidance explains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%

Last year

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

MiMedx receives FDA warning letter over Axiofill manufacturing concerns

Last year

Astellas hit with CRL for Claudin 18.2 drug due to third-party manufacturing issues

Last year

Senate health committee investigates inhaler manufacturers for high prices

Last year

FDA's Peter Marks says some secondary cancer cases after CAR-T therapy may be 'causal,' but benefits still outweigh risks: #JPM24

Last year

Califf and Marks call for clinicians to help address 'large volume' of vaccine misinformation

Last year

FDA lifts partial clinical hold on Innate's cancer drug after patient death linked to disease progression

Last year

House Republicans call on FDA to hand over info on internal scientific disagreements

Last year

Scoop: Resilience receives Form 483 due to mold at Canadian site, more layoffs anticipated

Last year

All the new drugs approved in 2023: Alzheimer's and gene therapy cap a five-year high

Last year

Dr. Reddy's, Torrent Pharma and Laurus Synthesis all land Form 483 letters following FDA inspections

Last year

Where are the adcomms? FDA has scheduled no drug or biologic meetings for 2024 so far

Last year

Pfizer gene therapy gets hemophilia B approval in Canada, setting stage for CSL rivalry

Last year

Updated: FDA says it has no plans for Israel-based office

Last year

Biden administration to use Defense Production Act to tackle drug shortages

Last year

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