Remove Doctors Remove FDA Approval Remove Therapies Remove Vaccine
article thumbnail

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

article thumbnail

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Therapy was initiated at Verquvo 2.5 KENILWORTH, N.J.–(BUSINESS

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The democratisation of cell and gene therapy

Drug Discovery World

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. Looking over the last five to eight years, he reflects on the handful of FDA approvals and CGTs that really work well.

Therapies 273
article thumbnail

T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

Eye on FDA

Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. And each day we are without a vaccine means these effects are going to linger. Why would COVID-19 affect a drug launch?

article thumbnail

New England Journal of Medicine Publishes 24-Week Results from Phase 3 Study Evaluating RINVOQ™ (upadacitinib) in Psoriatic Arthritis

The Pharma Data

at week 12 (p<0.001 for both doses), as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. at week 12.

Doctors 52
article thumbnail

VERQUVO® (vericiguat) Approved in the European Union

The Pharma Data

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

article thumbnail

New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable

The Pharma Data

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. TREMFYA is approved in the U.S., have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. •