Merck and Eisai Announce Promising Interim Results from LEAP-015 Trial of KEYTRUDA® and LENVIMA® in HER2-Negative Gastroesophageal Adenocarcinoma

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai announced results from the Phase 3 LEAP-015 trial evaluating KEYTR...

January 27, 2025 | Monday | News
Biogen's Higher Dose Regimen of Nusinersen for SMA Receives FDA and EMA Review

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Applicati...

January 24, 2025 | Friday | News
EU Approves Sarclisa in Combination with VRd for Newly Diagnosed Multiple Myeloma Patients Ineligible for Stem Cell Transplant

Following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)...

January 23, 2025 | Thursday | News
Sanofi’s Opella Achieves FDA Approval to Initiate OTC Cialis Use Trial

Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned a...

January 21, 2025 | Tuesday | News
ReciBioPharm Secures Gates Foundation Grant to Advance RNA Manufacturing Technologies for Global Health

3-year grant received from the Bill & Melinda Gates Foundation to enhance RNA production technologies Grant enables global implementation of the ...

January 21, 2025 | Tuesday | News
Junshi Biosciences Partners with LEO Pharma to Launch Toripalimab in Europe

Shanghai Junshi Biosciences Co., Ltd , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercializati...

January 21, 2025 | Tuesday | News
Valneva Announces Strong One-Year Phase 3 Results for IXCHIQ®, Its Single-Dose Chikungunya Vaccine in Adolescents

 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced additional positive Phase 3 results in adolescents for it...

January 21, 2025 | Tuesday | News
Novo Nordisk Announces Positive Results from STEP UP Phase 3b Trial for Semaglutide 7.2 mg in Obesity Treatment

Novo Nordisk  announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial i...

January 20, 2025 | Monday | News
Eli Lilly Secures FDA Approval for Omvoh® to Treat Moderately to Severely Active Crohn’s Disease

 Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for...

January 16, 2025 | Thursday | News
Pioneer Group Partners with Thermo Fisher to Empower Biotech Startups in Healthcare and Sustainability

Pioneer Group has  announced a collaboration agreement with Thermo Fisher Scientific to support biotech founders on their journey towards commerci...

January 16, 2025 | Thursday | News
Acadia Pharmaceuticals Submits Marketing Authorization Application for Trofinetide in the EU for Rett Syndrome Treatment

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the company has submitted a Marketing Authorization Application (MAA) to the European M...

January 15, 2025 | Wednesday | News
Grifols Receives $21 Million Grant from The Michael J. Fox Foundation to Advance Early Detection of Parkinson's Disease

Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a global healthcare company and leading producer of plasma-derived medicines, announced it has received a...

January 15, 2025 | Wednesday | News
AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan (Dato-DXd) Receives FDA Priority Review for EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Rev...

January 14, 2025 | Tuesday | News
HMNC Brain Health Reaches Key Milestone with Successful Patient Randomization in Phase 2b OLIVE Trial for Major Depressive Disorder

HMNC Brain Health (“HMNC”), a clinical-stage precision psychiatry biopharma company pioneering personalized treatments powered by predictive co...

January 14, 2025 | Tuesday | News

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