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AUTHOR: Anna Smith

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29 Aug 2019:

EU approval for Tecentriq combo

The approval of the monoclonal antibody was based on results from the Phase III IMpassion130 study. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/eu_approval_for_tecentriq_combo_1300025

18 Feb 2020:

Beovu bags EU approval in wet AMD

The drug is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid, compared to Bayer's Eylea. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/beovu_bags_eu_approval_in_wet_amd_1326378

15 Jan 2020:

PTC submits MAA for new gene therapy

The company expects a CHMP decision in the second half of 2020. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/ptc_submits_maa_for_new_gene_therapy_1322392

13 Feb 2019:

Spravato gets FDA Advisory Committee approval

FDA advisory committees have jointly voted in favour of approving Janssen's Spravato nasal spray CIII for adults living with treatment-resistant depression. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/spravato_gets_fda_advisory_committee_approval_1278162

29 Aug 2019:

FDA green light for Fasenra

Currently there are no FDA-approved treatments for eosinophilic oesophagitis. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/fda_green_light_for_fasenra_1300027

21 Jun 2019:

EU approval for Novo’s Esperoct

The decision follows the positive opinion from the CHMP. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/eu_approval_for_novos_esperoct_1292131

21 Jan 2020:

EMA licenses Mayzent for MS

Novartis also expects NICE and SMC decisions in the first half of 2020. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/ema_licenses_mayzent_for_ms_1322928

12 Apr 2019:

MSD’s Keytruda granted FDA extension

The approval is based on results from the Phase III KEYNOTE-042 trial. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/msds_keytruda_granted_fda_extension_1284352

7 Jan 2019:

Bristol-Myers Squibb to buy Celgene

Bristol-Myers Squibb has unveiled its intent to acquire Celgene in a deal worth $74 billion, in order to “create a premier innovative biopharma company”. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/bristol-myers_squibb_to_buy_celgene_1273944

21 Aug 2019:

NHS to reimburse Hemlibra

The 'life-changing' drug will be reimbursed for certain people with severe congenital haemophilia A. - News - PharmaTimes

by Anna Smith

https://www.pharmatimes.com/news/nhs_to_reimburse_hemlibra_1298460