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Novo Nordisk to Seek Rybelsus Expanded Label

[ Price : $8.95]

Novo Nordisk says it will submit a NDA supplement seeking an expanded label for its diabetes drug Rybelsus (semaglutide) based on ...

Pfizers Vyndagel Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Pfizers Vyndaqel (tafa...

NDA for Liver Cancer Combo Therapy Resubmitted

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FDA accepts for review an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, in combination with camre...

FDA Clears Design Changes to Zio AT

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FDA clears an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT cardiac telemetry device.

18 State Attorneys General Support Mifepristone Ruling

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A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower court decision finding that North ...

House GOPers Seek IG Probe on FDA Lab Safety

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House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDAs oversight a...

Regulatory Review Period for Pfizers Vyndamax

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pfizers Vyndamax (tafamidis...

FDA OKs Vyloy for Rare Gastric Cancer

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FDA approves an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing ch...

GE Recalls Neo-Natal Incubators

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GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the screw that secures the door becomi...

BioNTech Partial Hold on Lung Cancer Trial

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FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung ca...