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TXT Regulatory Review Period Determined for Aklief [94 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Galderma’s Aklief (trifarotene), indicated for topical treatment of acne vulgaris in patients nine years of age and older.
11/03/2021
 
 
TXT FDA Approves New Insightec Exablate Neuro Indication [2637 Words] [ Price : $8.95]
FDA approves Insightec’s Exablate Neuro for a third indication.
11/03/2021
 
 
TXT TecTraum Pro2Cool is Breakthrough Device [2666 Words] [ Price : $8.95]
FDA grants breakthrough device designation for TecTraum’s Pro2cool system to improve concussion outcomes.
11/03/2021
 
 
TXT FDA Oversight of Pfizer Covid Contractor Questioned [3007 Words] [ Price : $8.95]
A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the company’s work testing the Pfizer Covid-19 vaccine.
11/03/2021
 
 
TXT FDA Chief Scientist Hinton Leaves Agency [219 Words] [ Price : $8.95]
FDA chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton leaves the agency FDA to serve as deputy Surgeon General.
11/03/2021
 
 
TXT CDER Moving to Electronic CPPs 12/3 [2615 Words] [ Price : $8.95]
CDER says it is moving to electronic Certificates of Pharmaceutical Product as of 12/3.
11/03/2021
 
 
TXT FDA Extends PDUFA Date for Janssen BLA [2650 Words] [ Price : $8.95]
FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.
11/02/2021
 
 
TXT 9 QS Violations in CellEra Inspection [2904 Words] [ Price : $8.95]
FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile wound dressings.
11/02/2021
 
 
TXT Review Period Determined for Sarepta’s Vyondys 53 [78 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics’ Vyondys 53 (golodirsen).
11/02/2021
 
 
TXT Spinraza Gets Regulatory Review Determination [87 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogen’s Spinraza (nusinersen sodium).
11/02/2021
 
 
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