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
Roche Receives FDA 510(k) Clearance and CLIA Waiver for Cobas® Liat STI Multiplex Assay Panels

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvem...

January 23, 2025 | Thursday | News
Gilead Receives FDA Approval for Yescarta® Label Update, Showing Significant Overall Survival Benefit in Second-Line Treatment for Large B-Cell Lymphoma

Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axica...

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
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
MediBeacon's TGFR System Receives FDA Approval for Kidney Function Assessment

MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney fu...

January 20, 2025 | Monday | News
Kindeva Drug Delivery Secures $129M Contract to Supply DuoDote® Nerve Agent Antidote to U.S. Strategic National Stockpile

Kindeva Drug Delivery’s global health security division, Meridian Medical Technologies, LLC, secured a contract valued at up to $129 million t...

January 17, 2025 | Friday | News
OS Therapies Announces Positive Phase 2b Results for OST-HER2 in Preventing Recurrence of Lung Metastatic Osteosarcoma

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, ...

January 17, 2025 | Friday | 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
Incyte and Syndax Announce FDA Approval of Niktimvo™ for Chronic GVHD Treatment

 Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™...

January 16, 2025 | Thursday | News
Innovent Biologics’ IBI343 Receives Breakthrough Therapy Designation for Advanced Pancreatic Cancer in China

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...

January 16, 2025 | Thursday | News
Libtayo® Demonstrates Significant Improvement in Disease-Free Survival for High-Risk Cutaneous Squamous Cell Carcinoma in Phase 3 C-POST Trial

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment wi...

January 14, 2025 | Tuesday | News
Bayer Submits Supplemental New Drug Application for KERENDIA® (Finerenone) to Treat Heart Failure with Preserved or Mildly Reduced Ejection Fraction

Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone...

January 13, 2025 | Monday | News
Revvity Secures FDA Clearance for EUROIMMUN’s Groundbreaking Free Testosterone Test

-Revvity, Inc.  announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemilu...

January 13, 2025 | Monday | News

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