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Positive Results in Pfizer RSV Vaccine Trial

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Pfizer says it will seek regulatory approval this fall for its respiratory syncytial virus prefusion F vaccine candidate.

Medical Device Export Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Export of Medical Devices; Foreign Letters ...

WLF Post Looks at Pfizers Copay Subsidy Program

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Writing in an online Washington Legal Foundation post, Goodwin Procter partner Matt Wetzel examines a recent appeals court decisio...

FDA Approves Abbott Proclaim Plus System

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FDA approves Abbotts new Precision Plus spinal cord stimulation system.

BioMarin Refiling BLA for Hemophilia A Gene Therapy

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BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocoge...

Califf Says No Panel Will Review Covid Boosters

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FDA commissioner Robert Califf says there are no new questions on the recently submitted Covid-19 booster vaccines and the agency ...

Comments on Breakthrough Therapy Recission Draft

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Three stakeholders comment on an FDA draft guidance on rescinding breakthrough therapy designations.

Imbruvica Pediatric sNDA Approved by FDA

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FDA approves a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for certain pediatric patients over one year of age with c...

FDA Releases 3 Drug Safety-Related Label Changes

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FDA publishes drug safety-related labeling changes for Gleevec and Rapamune.

House Committee on Trump's Covid Pressure on FDA

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A House Select Subcommittee on the Coronavirus Crisis report details evidence of what it sees as inappropriate Trump administratio...