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Samsung Bioepis`s Biologic Epysqli Receives Suppl Approval in US
15 Nov 2024 //
FDA
Samsung Bioepis Presents Data On EPYSQLI At European Society
23 Sep 2024 //
GLOBENEWSWIRE
Alexion`s Biologic Soliris (Eculizumab) Receives Suppl Approval in US
19 Sep 2024 //
FDA
FDA Approves Samsung Bioepis` EPYSQLI As Biosimilar To Soliris
22 Jul 2024 //
GLOBENEWSWIRE
Samsung Bioepis`s Biologic Epysqli (Eculizumab) Receives Approval in US
19 Jul 2024 //
FDA
Samsung Bioepis Presents EPYSQLI Post-Hoc Analysis At EHA
14 Jun 2024 //
GLOBENEWSWIRE
Samsung Bioepis Eculizumab Biosimilar EPYSQLI Post-Hoc Analysis At EHA
30 May 2024 //
GLOBENEWSWIRE
US FDA approves Amgen`s biosimilar to AZ`s rare blood disorder treatment
29 May 2024 //
REUTERS
FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
28 May 2024 //
PR NEWSWIRE
SEC recommends import, marketing permission for AstraZeneca`s rare disease drug
30 Apr 2024 //
PHARMABIZ
Voydeya approved in the EU as add-on treatment to ravulizumab
23 Apr 2024 //
PRESS RELEASE
Voydeya recommended for approval in the EU by CHMP
26 Feb 2024 //
PRESS RELEASE
Alexion Pharma`s Biologic Soliris (eculizumab) Receives Approval in the U.S.
09 Feb 2024 //
FDA
PIII trial data showed danicopan as add-on to ULTOMIRIS sustained improvements
10 Dec 2023 //
BUSINESSWIRE
Soliris approved in Japan for paediatric patients with gMG
24 Aug 2023 //
PRESS RELEASE
AstraZeneca secures paediatric gMG approval for Soliris in EU
28 Jul 2023 //
PRESS RELEASE
Amgen`s Bekemv (eculizumab) Approved In Europe
06 Jul 2023 //
EMA
Soliris recommended for approval in the EU by CHMP for children with gMG
27 Jun 2023 //
PRESS RELEASE
AstraZeneca’s Soliris given EU CHMP recommendation for marketing authorisation
26 Jun 2023 //
PHARMATIMES
Soliris approved for the treatment of refractory generalised myasthenia gravis
13 Jun 2023 //
PRESS RELEASE
Samsung Bioepis`s Epysqli (Eculizumab) Receives Approval in the Europe
31 May 2023 //
EMA
European Commission approves haematology biosimilar
30 May 2023 //
EUROPEAN PHARMACEUTICAL REVIEW
AZ showcases advances across rare and malignant haematological conditions
17 May 2023 //
PHARMABIZ
Amgen Technology`s Bekemv (Eculizumab) Receives Approval in the Europe
15 May 2023 //
EMA
Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar
31 Mar 2023 //
GLOBENEWSWIRE
Health Canada grants approval for Sobi’s PNH therapy
12 Dec 2022 //
PHARMACEUTICAL-TECHNOLOGY
Danicopan Add-On to ULTOMIRIS or SOLIRIS Met Primary Endpoint in ALPHA PIII
16 Sep 2022 //
BUSINESSWIRE
Danicopan (ALXN2040) Add-On to ULTOMIRIS® or SOLIRIS® (eculizumab)
16 Sep 2022 //
BIOSPACE
ImmunAbs Inc. Announces US FDA Approval for a Phase 1 Clinical Trial
03 Aug 2022 //
BUSINESSWIRE
Samsung Bioepis Presents New Phase 3 Study of SB12 (Eculizumab)
09 Jun 2022 //
GLOBENEWSWIRE
AZ`s rare disease rising star Ultomiris snags 3rd FDA nod
29 Apr 2022 //
FIERCEPHARMA
AstraZeneca`s Alexion, Arvinas nab space at new biotech tower
16 Apr 2022 //
FIERCEBIOTECH
Argenx`s Vyvgart is already winning neurologist support
17 Feb 2022 //
FIERCEPHARMA
Soliris needs a 97% to 98% discount in myasthenia gravis: ICER
21 Oct 2021 //
FIERCEPHARMA
ICER Publishes Evidence Report on Treatments for Myasthenia Gravis
10 Sep 2021 //
FIRSTWORDPHARMA
AstraZeneca lays out the red carpet for rare disease drug Alexion paid $855M for
26 Aug 2021 //
ENDPTS
EU regulator backs AZ drug for rare blood disorder in children
27 Jul 2021 //
REUTERS
Soliris needs substantial discount in myasthenia gravis: ICER
23 Jul 2021 //
FIERCEPHARMA
BMS takes another late-stage loss for Opdivo-Yervoy combo in head & neck cancer
17 Jul 2021 //
ENDPTS
Days after FDA clears C3 drug, Apellis spotlights ex-US PhIII win
26 May 2021 //
ENDPTS
Apellis to Present Long-Term Pegcetacoplan Data at the EHA Congress
12 May 2021 //
GLOBENEWSWIRE
NICE recommends Alexion’s PNH treatment Ultomiris
15 Apr 2021 //
NEUROEUROPE
First approved C5 complement inhibitor recommended by NICE for NHS use
14 Apr 2021 //
PHARMAFILE
Alexion`s Soliris (eculizumab) Receives Supplemental Approval in US
24 Nov 2020 //
FDA
Apellis` Soliris rival gets a date at the FDA for a rare blood disorder
17 Nov 2020 //
ENDPTS
PMDA Reviewing New Safety Risks for Soliris, Venclexta/Noxafil
16 Nov 2020 //
JIHO
Novartis succeeds where Alexion failed, coming up with a win for a prized asset
27 Oct 2020 //
ENDPTS
Novartis targets Alexion`s fiefdom after showing safe switch from Soliris
31 Aug 2020 //
FIERCE BIOTECH
FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)
18 Aug 2020 //
PRESS RELEASE
Alexion and Amgen Settle IPRs Over SOLIRIS (eculizumab)
12 Jun 2020 //
BIGMOLECULELAW
DKSH extends long-term rare disease partnership in Hong Kong, Macau and Taiwan
11 Jun 2020 //
PRESS RELEASE
New Pivotal Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab
11 Jun 2020 //
PRESS RELEASE
Alexion Settles With Amgen Over Eculizumab Patents
02 Jun 2020 //
CENTERFORBIOSIMILAR
For a post-Soliris world, Atlas-backed Q32 Bio outlines $46M next-gen
27 May 2020 //
ENDPTS
Genentech posts long-term data on near-approval Soliris rival
22 May 2020 //
FIERCE BIOTECH
Alexion will test rare disease drug Ultomiris in severe COVID-19
21 Apr 2020 //
PMLIVE
Alexion`s Soliris (Eculizumab ) Receives Supplemental Approval in US
09 Apr 2020 //
FDA
Alexion`s Soliris (Eculizumab) Receives Supplemental Approval In US
07 Apr 2020 //
FDA
Alexion counts switching campaign, pipeline among 2019 wins
30 Jan 2020 //
FIERCE PHARMA
