FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Extends PDUFA Date for Janssen BLA

[ Price : $8.95]

FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.

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

[ Price : $8.95]

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

Spinraza Gets Regulatory Review Determination

[ Price : $8.95]

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

Regulatory Review Determined for Daiichis Enhertu

[ Price : $8.95]

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

FDA Approves Novartis Scemblix for Some Leukemias

[ Price : $8.95]

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

Breakthrough Designation for Renew Cerezen

[ Price : $8.95]

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

Amylyx Pharmaceuticals NDA for ALS Drug

[ Price : $8.95]

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

FDA Accepts NDA for Parsaclisib in Lymphomas

[ Price : $8.95]

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

ANI Pharma sNDA for Purified Cortrophin Gel

[ Price : $8.95]

FDA approves an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain c...