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Novartis Experimental Therapy Bests C5 Inhibitors in Phase 3 PNH Study

Novartis Experimental Therapy Bests C5 Inhibitors in Phase 3 PNH Study
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AGG Food & Drug Newsletter - July 2022 | Arnall Golden Gregory LLP

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our.

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Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission | Arnall Golden Gregory LLP

In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other.

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AstraZeneca s Enhertu Granted Breakthrough Therapy Designation In U S For Metastatic Breast Cancer

LONDON (dpa-AFX) - Daiichi Sankyo and AstraZeneca's (AZN, AZN.L) Enhertu has been granted Breakthrough Therapy Designation in the U.S. for the treatment of adult patients with unresectable or metastatic

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TEZSPIRE™ (TEZEPELUMAB-EKKO) NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA

/PRNewswire/ Amgen (NASDAQ:AMGN) and AstraZeneca today announced TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S..

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