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Telix NDA Resubmission for Brain Cancer Imaging Agent

[ Price : $8.95]

FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.

FDA Cites Manufacturing, Quality Lapses at Orchid Pharma

[ Price : $8.95]

FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by O...

Lucemyra Web Site Home Page False or Misleading: FDA

[ Price : $8.95]

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucemyra.

Vanda Blasts FDA Plan to Lengthen Drug Review Times

[ Price : $8.95]

Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen N...

FDA, Device Industry Reach Agreement on MDUFA VI

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FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations...

Medline Class 1 Recall of Angiographic Control Syringes

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Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death.

Will the Push for DTC Pre-Review Grow?

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Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-revie...

RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

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HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the T...

Alymsys Patient Brochure False or Misleading: FDA

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The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misl...

America First Fee Incentives Discussed in PDUFA Meeting

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Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee i...