Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2018-05-03 | atidarsagene autotemcel | Orchard Therapeutics (UK) |
|
Granting of a Market Authorisation in the EU |
2018-08-07 | synthetic stereopure antisense oligonucleotide specific for human dystrophin pre-messenger ribonucleic acid (mRNA) | Wave LIfe Sciences (USA - MA) | Duchenne muscular dystrophy | Granting of the orphan status in the US |
0000-00-00 | (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide | BeiGene (China) | relapsed/refractory mantle cell lymphoma (MCL) | Acceptation for review of a NDA |
2018-08-31 | tislelizumab | Beigene (China) | relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) | Acceptation for review of a NDA |
2018-07-30 | trastuzumab (biosimilar product) | Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the EU |
2018-03-12 | golodirsen | Sarepta Therapeutics (USA - MA) | Duchenne Muscular Disease (DMD) | Submission of a Market Application in the US |
2018-05-16 | self-complementary non-replicating, recombinant adeno-associated virus serotype rhesus 74 (rh 74) expressing the human beta-sarcoglycan gene under the control of the muscle creatine kinase (MHCK7) promoter | Myonexus Therapeutics (USA - OH) |
|
Granting of the orphan status in the US |
2018-09-05 | Pfizer (USA - NY) | alopecia areata | Granting of the Breakthrough Therapy status | |
0000-00-00 | engineered recombinant human acid alpha-glucosidase (rhGAA) | Amicus Therapeutics (USA - NJ) | Pompe disease | Submission of a Market Application in the US |
2018-09-06 | Virtrial (USA - AZ) | Product launch | ||
2018-09-13 | moxetumomab pasudotox | AstraZeneca (UK) |
|
Granting of a Market Authorisation in the US |
2017-08-17 | tetravalent tandem diabody binding both CD3 and CD33 | Amphivena Therapeutics (USA - CA) | acute myeloid leukemia | Granting of the orphan status in the US |
2018-02-14 | recombinant humanized IgG4 monoclonal antibody against pHERV-W Envelope protein | Geneuro (Switzerland) | chronic inflammatory demyelinating polyneuropathy (CIDP) | Granting of the orphan status in the US |
2018-09-10 | Amicus Therapeutics (USA - NJ) | Pompe disease | Submission of a Market Application in the US | |
2018-09-21 | recombinant human factor VIII (rFVIII) - damoctogog alfa pegol | Bayer (Germany) | hemophilia A | Granting of a Market Authorisation in Japan |
2018-09-20 | doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) | Merck&Co (USA - NJ) | HIV-1 infection in adults | Positive opinion for the granting of a Market Authorisation in the EU |
2018-08-08 | daratumumab | Janssen Biotech, a J&J company (USA - NJ) | split dosing regimen | Submission of an sNDA |
2017-07-05 | Y-mAbs Therapeutics (USA - NY, Denmark) | neuroblastoma | Granting of a Fast Track status | |
2018-08-21 | naxitamab | Y-mAbs Therapeutics (USA - NY, Denmark) | neuroblastoma | Granting of the Breakthrough Therapy status |
2018-09-20 | galcanezumab | Eli Lilly (USA -IN) | prevention of migraine in adults | Positive opinion for the granting of a Market Authorisation in the EU |
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