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FDA Urges High Court Rejection of Vanda Petition

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FDA urges the Supreme Court to reject Vanda Pharmaceuticals petition challenging the agencys decision to deny fast-track status fo...

3 Observations from Lupin Pithampur Inspection

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FDA releases the form FDA-483 with three observations from its inspection at the Lupin drug manufacturing facility in Pithampur, M...

Orphan Status for Minovia Myelodysplastic Drug

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Minovia Therapeutics wins an FDA orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndro...

FDA Accepts Chiesis Triple Combination Asthma Inhaler

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FDA accepts for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults...

Former Deputy Commissioner Bumpus Joins Charles River

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Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as chair a new global scientific advis...

FDA Warns on RF Microneedling Devices

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FDA warns of serious complications associated with certain uses of radiofrequency microneedling devices, commonly used in aestheti...

Trial Success for Lilly Oral GLP-1

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Lilly says its investigational oral GLP-1 drug demonstrated good glycemic control in two Phase 3 trials.

FDA Clears Roche Alzheimers Test

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FDA clears Roches Elecsys pTau 181 blood-based biomarker test for an initial Alzheimers disease assessment.

6 Observations in Hetero Labs 483

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FDA releases the 12-page form FDA-483 with six observations from an inspection at Indias Hetero Labs Unit 9 API manufacturing faci...

Akamis Bio Gets Fast Track for Rectal Cancer Drug

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FDA grants Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient locally advanced rectal cancer.