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FDA approves pharma company's new drug application
A new report looks at hiring trends © 2025 American City Business Journals. All rights reserved. Use of and/or registration ...
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
Targeted Oncology1d
FDA Reviews All-Oral Decitabine/Cedazuridine/Venetoclax Combo in AML
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
MPR1d
PSVT Treatment Etripamil Nasal Spray Gets Another FDA Review
The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...
Stocktwits on MSN1d
FDA May Fast-Track New Drug Reviews In Return For Companies Lowering Drug Prices: Report
The U.S. Food and Drug Administration may reportedly fast-track new drugs from pharmaceutical companies that “equalize” the ...
BioSpace1d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
BioSpace1d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg
FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...
Medical Marketing & Media2d
Rx Rundown: Merck, Gilead Sciences, Apogee Therapeutics and more
Amarna Therapeutics and NorthX Biologics finalized an agreement to advance Nimvec AM510 gene therapy toward clinical trials for Type 1 Diabetes. Now in its fourth year, the MM+M Media Summit brings ...
Medscape2d
New HIV Prevention Drug Holds Promise for Australia
A twice-yearly injection could help Australia eliminate HIV, but experts are sounding the alarm over its prohibitive cost.