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Human Drugs

Justice Petitions Supreme Court Over Mifeprex

The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of Appeals that would ...

Biologics

Updated Covid-19 Vaccines Approved by FDA

FDA gives the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely target currently circ...

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Human Drugs

Tagrisso Phase 3 Data in Lung Cancer

AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy in lung cancer patients extended median prog...

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Human Drugs

Pregnancy Safety Study Workshop Planned

FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.

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CMC Readiness Pilot Program

Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pil...

Medical Devices

S4 De Novo Authorization for esolution

FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.

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Human Drugs

Novartis Recalls Sandimmune Lot

Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottle...

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Medical Devices

FDA Updates Alert on Halyard N95 Masks

FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators ...

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Human Drugs

Senators Reintroduce Opioid Studies Bill

U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduce their bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act.

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Human Drugs

House Committee Hearing on Drug Shortages

The House Energy and Commerce Committee announces a 9/14 legislative hearing to discuss legislative proposals on preventing generic drug shortages.