FDA Accepts Resubmission for Dupixent to Treat Chronic Spontaneous Urticaria (CSU)

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (d...

November 18, 2024 | Monday | News
Amgen Presents New Data on UPLIZNA and KRYSTEXXA at ACR Convergence 2024

Amgen (NASDAQ:AMGN) announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheum...

November 15, 2024 | Friday | News
GSK’s Blenrep Combination Demonstrates Significant Survival Benefit in Relapsed/Refractory Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Bl...

November 15, 2024 | Friday | News
BioNTech Acquires Biotheus to Strengthen Oncology Pipeline with Bispecific Antibody Asset BNT327/PM8002

BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Biotheus (“Biotheus”) announced the signing of a definitive agreement for...

November 14, 2024 | Thursday | News
Gilead’s Lenacapavir Demonstrates Strong Efficacy and High Adherence in Phase 3 PURPOSE 2 Trial for HIV Prevention

Gilead Sciences, Inc. (Nasdaq: GILD) presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is stu...

November 14, 2024 | Thursday | News
TAE Life Sciences and Stella Pharma Announce Exclusive Collaboration to Expand BNCT Therapy in the U.S. and Europe

TAE Life Sciences (TLS), a leader in boron neutron capture therapy (BNCT) technology, and Stella Pharma, the pioneering developer of the boronophenylalan...

November 14, 2024 | Thursday | News
NurExone Gains EMA Orphan Designation for ExoPTEN, Advancing Spinal Cord Injury Therapy Across Europe

NurExone Biologic Inc.  a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the European Medici...

November 14, 2024 | Thursday | News
Tirzepatide Reduces Type 2 Diabetes Risk by 94% in Three-Year SURMOUNT-1 Study, Lilly Reports

SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three y...

November 14, 2024 | Thursday | News
Bio-Rad Advances Oncology Diagnostics with IVDR Certification for CML Assay and Strategic Collaborations in MRD and ctDNA Detection

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, announced updates on its onco...

November 13, 2024 | Wednesday | News
Alexion and Merck Report Positive Phase 3 KOMET Trial Results for KOSELUGO in Treating Adult Patients with Neurofibromatosis Type 1

Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced positive topline results from the ...

November 13, 2024 | Wednesday | News
IDEAYA Secures Global Rights to Biocytogen’s Innovative BsADC Candidate, IDE034

IDEAYA Secures Exclusive Global License for Biocytogen’s First-In-Class BsADC, B7H3/PTK7 Topo-I Payload (IDE034), Validating Biocytogen’s Ren...

November 12, 2024 | Tuesday | News
Perceptive eClinical Launches ClinPhone 5: An Innovative RTSM Platform to Transform Clinical Trials

Perceptive eClinical, part of Perceptive Group, is pleased to announce the launch of ClinPhone 5, a ground-breaking new Randomization and Trial Supply Mana...

November 12, 2024 | Tuesday | News
ResQ Pharma Receives PDUFA Date for FDA Review of LipidRescue Kit for Life-Threatening Anesthetic Reactions

ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, announced that it has received a P...

November 12, 2024 | Tuesday | News
Abbisko's Phase 3 Study of Pimicotinib Shows Statistically Significant Efficacy in Treating Tenosynovial Giant Cell Tumor (TGCT)

Abbisko announced that the Phase 3 MANEUVER study evaluating pimicotinib in the treatment of tenosynovial giant cell tumor (TGCT) achieved statistically si...

November 12, 2024 | Tuesday | News

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