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9 QS Violations in CellEra Inspection

[ Price : $8.95]

FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile w...

Review Period Determined for Sareptas Vyondys 53

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics Vyondy...

Spinraza Gets Regulatory Review Determination

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Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogens Spinraza (nusiner...

Regulatory Review Determined for Daiichis Enhertu

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Enhertu.

FDA Approves Novartis Scemblix for Some Leukemias

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FDA approves Novartis Scemblix for two distinct chronic myeloid leukemia indications.

Breakthrough Designation for Renew Cerezen

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FDA grants breakthrough device designation to Renew Biosciences Cerezen device to treat mild cognitive impairment associated with ...

Amylyx Pharmaceuticals NDA for ALS Drug

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Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic later...

FDA Accepts NDA for Parsaclisib in Lymphomas

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FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular ...

FDA Withdrawing 18 No-Longer-Marketed NDAs

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Federal Register notice: FDA withdraws approval of 18 NDAs from multiple applicants because the drug products are no longer market...

Moderna Delaying Pediatric Covid Vaccine EUA Filing

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Moderna says ongoing FDA safety concerns with Modernas Covid-19 vaccine and its potential use in adolescents has led to a filing d...