Agenus announces U.S. FDA acceptance and priority review of balstilimab biologics license application for the treatment of recurrent or metastatic cervical cancer

17 June 2021 - Agenus today announced that the U.S. FDA has accepted Agenus’ biologics license application for balstilimab, an ...

Read more →

United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review

16 June 2021 - FDA action expected in October 2021. ...

Read more →

GBT’s voxelotor is first sickle cell disease treatment to receive promising innovative medicine designation in the UK

14 June 2021 - Global Blood Therapeutics announced today that the MHRA in the United Kingdom has granted a Promising Innovative ...

Read more →

FDA grants priority review for new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa

3 June 2021 - PDUFA date of 30 November 2021 set for Oleogel-S10. ...

Read more →

CTI BioPharma announces acceptance of NDA granted with priority review of pacritinib for treatment of patients with myelofibrosis

1 June 2021 - PDUFA action date 30 November 2021. ...

Read more →

Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing

1 June 2021 - Lannett  today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...

Read more →

BeyondSpring announces U.S. FDA acceptance and priority review of new drug application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia

1 June 2021 - The FDA has set a Prescription Drug User Fee Act target action date for 30 November 2021. ...

Read more →

Ipsen confirms U.S. FDA accepts new drug application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva

28 May 2021 - New drug application granted priority review status, with a decision anticipated on 30 November 2021. ...

Read more →

U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma

26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...

Read more →

U.S. FDA grants priority review of maribavir for the treatment of post-transplant recipients with cytomegalovirus infection in those resistant and/or refractory to prior anti-CMV treatment

21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority ...

Read more →

BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for Brukinsa (zanubrutinib) in marginal zone lymphoma

19 May 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa ...

Read more →

Merck and Eisai receive priority review from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) applications for advanced renal cell carcinoma and for advanced endometrial carcinoma

6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 ...

Read more →

Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma

5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for ...

Read more →

U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma

30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...

Read more →

FDA grants priority review for Nefecon for patients with IgA nephropathy

28 April 2021 - Calliditas Therapeutics today announced that the U.S. FDA has accepted the submission and granted priority review for ...

Read more →