Monday, December 9, 2024

CATEGORY

Johnson & Johnson

Lung Cancer Treatment: European Commission Approves RYBREVANT®▼ (Amivantamab) with Chemotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Key Takeaways:Lung cancer patients with advanced EGFR-mutated NSCLC now have a new treatment option with the European Commission's approval of RYBREVANT® (amivantamab) in...

European Commission Approves BALVERSA® for Metastatic Urothelial Carcinoma

Key Takeaways:Janssen's BALVERSA® (erdafitinib) has been approved by the European Commission for the treatment of metastatic urothelial carcinoma with FGFR3 alterations. This approval...

Johnson & Johnson Acquires V-Wave to Strengthen Cardiovascular Portfolio

Johnson & Johnson has entered a definitive agreement to acquire V-Wave Ltd., a company focused on innovative treatments for heart failure. This acquisition is...

Lung Cancer Treatment Advancement: FDA Approves Lazertinib and Amivantamab-vmjw for Non-Small Cell Lung Cancer

Lung cancer patients have new hope with the FDA's recent approval of lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech,...

Understanding Value-Based Pricing in Medical Devices: Aligning Cost with Patient Outcomes and Healthcare Efficiency

10 Key Takeaways from "Understanding Value-Based Pricing in Medical Devices: Aligning Cost with Patient Outcomes and Healthcare Efficiency":Shift from Traditional Pricing Models: Value-based...

Heart Pumps: FDA Recalls J&J’s Abiomed Devices After Failed Lot Inspections

Heart pumps, particularly the Impella CP with SmartAssist devices from Abiomed, have recently come under scrutiny as the U.S. Food and Drug Administration (FDA)...

Awareness Raised on Risks Tied to J&J’s Megadyne Recall by FDA and Health Canada

Awareness of the risks tied to Megadyne electrode pads is being raised by the Food and Drug Administration (FDA) and Health Canada. The FDA...

Lung Cancer Breakthrough as EMA Recommends Approval of RYBREVANT Plus Chemotherapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of RYBREVANT® for treating adult...

Myeloma Treatment Expanded with FDA Approval of Darzalex Faspro

Myeloma treatment expanded with the US Food and Drug Administration (FDA) and the FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research and...

Biosimilar FYB202 by Fresenius Kabi and Formycon Receives Positive CHMP Opinion for Treatment

Fresenius Kabi, an operating company of Fresenius specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and...

CHMP Approves New Medicines and Biosimilars, Rejects Eisai and Biogen’s Alzheimer’s Drug

Despite the typical summer slowdown, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has shown no signs of reducing...

Johnson & Johnson Submits SPRAVATO® for FDA Approval as Monotherapy

Johnson & Johnson (NYSE: JNJ) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration...

Pricing of J&J Drugs Enters Medicare Negotiations as Company Maintains 2025 Guidance

Pricing negotiations for Johnson & Johnson’s (J&J) top-selling drugs—Stelara, Xarelto, and Imbruvica are underway with Medicare, but the pharmaceutical giant does not foresee a...

Multiple Myeloma Treatment: Carvykti Shows Significant Improvement in Relapsed or Lenalidomide-Refractory Patients After One Prior Therapy

Multiple myeloma patients with relapsed or lenalidomide-refractory disease, after receiving one prior line of therapy, showed statistically significant and clinically meaningful improvement in overall...

Pulmonary Tuberculosis Treatment Gains Full FDA and EC Approval for Johnson & Johnson’s SIRTURO®

Johnson & Johnson has received traditional approval from the U.S. Food and Dug Administration (FDA) and full approval from the European Commission (EC) for...

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