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2 Companies Pause Some CAR T Studies

[ Price : $8.95]

Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse eve...

FDA Backs PFAS Used in Medical Devices

[ Price : $8.95]

FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices...

Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function

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FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, a...

IDEAYA Plans Phase 3 Study in Lung Cancer After FDA Meeting

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IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extens...

Karyopharm sNDA Filed for Xpovio in Myelofibrosis

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Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitin...

FDA, SEC Sign MOU on Sharing Info on Medical-Product Companies

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FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving compani...

D.C. Circuit Raises Bar for Generic Drug Exclusivity

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An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after mis...

FDA, Regulatory Partners Agree on Alternative Endotoxin Test

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FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach...

Rules Needed on Complete Response Letter Transparency: Researchers

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Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.

First Oral Drug Indicated to Treat Dermatomyositis Approved

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The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.