Tag: David M. Reese

LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC

businessnewstoday- May 29, 2021 0

LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a ... Read More

Amgen gets breakthrough therapy status for sotorasib in China

pharmanewsdaily- January 31, 2021 0

Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National ... Read More

Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma

pharmanewsdaily- August 23, 2020 0

DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the ... Read More

Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

pharmanewsdaily- December 20, 2019 0

Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food ... Read More

CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients

pharmanewsdaily- September 13, 2019 0

CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson's Darzalex (daratumumab) ... Read More

Amgen seeks FDA approval for infliximab biosimilar ABP 710

pharmanewsdaily- December 18, 2018 0

Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & ... Read More

FDA approves new dosing option for Amgen blood cancer drug Kyprolis

pharmanewsdaily- October 2, 2018 0

The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone ... Read More

AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation

pharmanewsdaily- September 9, 2018 0

UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The ... Read More

Amgen blood cancer drug BLINCYTO scores EC approval in pediatric patients

pharmanewsdaily- August 30, 2018 0

The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of ... Read More