Vertex Pharmaceuticals Announces FDA Approval of JOURNAVX™ (Suzetrigine) for Acute Pain Treatment

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzet...

January 31, 2025 | Friday | News
Roche Announces Positive Overall Survival Results for Itovebi™ in Advanced Breast Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study investigating...

January 29, 2025 | Wednesday | News
Merck’s WELIREG® (belzutifan) Accepted for Priority Review by FDA for Advanced Pheochromocytoma and Paraganglioma

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for prior...

January 28, 2025 | Tuesday | News
Norgine and X4 Pharmaceuticals Celebrate EMA Validation of Mavorixafor for WHIM Syndrome

Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 that their Marketing Authorization Applicatio...

January 27, 2025 | Monday | News
Biogen’s LEQEMBI® Gains FDA Approval for Once Every Four Weeks Maintenance Dosing in Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

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
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

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