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SCOTUS Should Hear Label Highlights Appeal: PhRMA

[ Price : $8.95]

PhRMA asks the Supreme Court to reverse an 11th Circuit Appeals Court decision that held Shire could unilaterally change the Highl...

FDA Enforcement Discretion Policy for Pandemic Tests

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FDA develops a policy for the use of enforcement discretion for unauthorized tests in public health emergencies.

FDA Stalls Xspray Pharmas Dasynoc

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FDA issues a complete response letter for the Xspray Pharma Dasynoc NDA, asking for additional dosing information and information ...

Takeda Withdraws BLA for Dengue Vaccine

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Takeda withdraws a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on aspects of data collection...

FDA Clears Avatar VR Surgical Planner

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FDA clears the Avatar Medical virtual reality surgical planning solution.

Cipla Recalls 6 Albuterol Sulfate Aerosol Batches

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FDA says Cipla has recalled six batches of albuterol sulfate inhalation aerosols due to a container defect that could lead the inh...

FDA Lifts Partial Hold on Curis Leukemia Trial

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FDA lifts a partial clinical hold on the Curis Phase 1/2 trial of emavusertib in the TakeAim Leukemia study.

DTC Guidance May Signal Enforcement Shift: Attorneys

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Three Hogan Lovells attorneys say a recently finalized FDA guidance on DTC drug promotion may signal an increase in promotion enfo...

Illumina Cybersecurity Vulnerability is Class 2: FDA

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DA says a cybersecurity vulnerability in several Illumina DNA sequencing devices is Class 2.