On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its...
BeiGene’s BLA for TEVIMBRA® (tislelizumab) Accepted by FDA for Treatment of First-Line Gastric or Gastroesophageal Junction Cancers
On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene's Biologics...
CHMP Recommends AZ’s Voydeya® (danicopan) with Ravulizumab or Eculizumab
On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
CHMP Issues Positive Opinion for BeiGene’s TEVIMBRA® (tislelizumab) for NSCLC
On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European...
Takeda Pharmaceuticals Releases Long term results of IV SC Vedolizumab Switching Study
On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn's...
Approval Alert: First Aflibercept Biosimilar Approved in Korea, as Samsung Bioepis’ Afilivu® Gets the Green Light
On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of...
Alvotech Shares Rise Premarket After SIMLANDI® (Biosimilar to AbbVie’s Humira® (adalimumab)) Approval by FDA
On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per...
Samsung Bioepis Presented Study Results for ustekinumab SB17, Biosimilar to Janssen’s Stelara®, at ECCO
On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s...
Approval Alert: Alvotech announces US approval of First High Concentration Buffer Free Interchangeable Adalimumab Biosim
Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable...
Eli Lilly’s Donanemab Nears FDA Approval Decision
On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab...
Regeneron Announces FDA priority review of Dupixent® (Dupilumab) for the treatment of COPD with type 2 inflammation
On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®'s...
Approval Alert: FDA fast tracks Artiva Biotherapeutics’ AlloNK® (AB-10)
On February 2024, Artiva Biotherapeutics announced that the FDA granted fast-track designation to its Lupus Nephritis...
AstraZeneca Acquires Gracell Biotechnologies for $1.2B
AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical...
Samsung Bioepis’ ustekinumab biosimilar Pyzchiva® (SB17) Recommended for EU Approval
On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung...
Coherus launches Udenyca OnBody® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®
Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca®...
Polpharma Biologics Demonstrates Comparability of PB016 (vedolizumab) and Entyvio®
On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK)...