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Feb 27, 2024
On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL). ...
Feb 27, 2024
On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene's Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date...
Feb 26, 2024
On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumab or eculizumab for the treatment of adult patients...
Feb 26, 2024
On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung...
Feb 26, 2024
On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn's & Colitis 360. The study involved 108 patients switched from IV to a subcutaneous vedolizumab. The results of the study suggested that switching...
Feb 26, 2024
On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept). This is the first aflibercept biosimilar approved in Korea and...
Feb 26, 2024
On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share. Alvotech's U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved...
Feb 23, 2024
On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden. The results demonstrate SB17 is highly similar...
Feb 23, 2024
Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®. SIMLANDI® is the first high concentration adalimumab product to be US approved. It is...
Feb 23, 2024
On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this year. This news comes after Phase 3 clinical trial results...
Feb 23, 2024
On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®'s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target...
Feb 22, 2024
On February 2024, Artiva Biotherapeutics announced that the FDA granted fast-track designation to its Lupus Nephritis treatment AlloNK®(AB-10) in combination with rituximab or obinutuzumab. This was supported by the results of a phase I/II multicentre clinical trial...
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