Windtree has manufacturing contacts that we believe are capable of reducing pharmaceutical product cost of goods for PHEXXI. Pursuant to the License and Supply Agreement, Windtree will serve as the ...
FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of ...
THURSDAY, March 20, 2025 (HealthDay News) -- A newly approved clot- busting drug for stroke works as well as a decades-old ...
FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.
Zacks Investment Research on MSN21h
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for ReviewDr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...
The future of American drug innovation is threatened by US regulations that permit knockoff versions of new drugs to be sold ...
The exorbitant costs of drugs like Wegovy — especially compared to other countries — have prompted some insurers to tighten ...
Some major decisions on the future of reproductive rights and access to abortion are active in our courts right now. Some of ...
The FDA approved a prefilled syringe format for Ani's purified Cortrophin Gel that should ease administration for MS patients ...
New treatments have changed the face of managing hemophilia with an inhibitor, columnist Cazandra Campos-MacDonald writes.
Dima Hendricks has sickle cell disease, which is currently managed by an old medication, but she is hoping to take part in a ...
It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...
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