News

Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...
MPR7d
FDA Approves Self-Administration Option for Vyvgart Hytrulo
After proper training on subcutaneous injection technique, the prefilled syringe may be administered by the patient or caregiver.
Drug Store News7d
FDA grants interchangeable designation for Celltrion’s Yuflyma
Yuflyma is a high-concentration and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory ...
Newsweek on MSN19h
FDA Commissioner Announces Plan to Eliminate Synthetic Food Dyes
FDA Commissioner Marty Makary announced a phaseout of eight synthetic food dyes—including Red 40—by 2026. The FDA will set ...
Sedana Medical AB: Sedana Medical Receives FDA Approval for Early Access Program in the U.S.
Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sed ...
Contract Pharma8d
Celltrion’s YUFLYMA Approved as Interchangeable Biosimilar to Humira
The U.S. Food and Drug Administration has designated Celltrion Inc.’s YUFLYMA (adalimumab-aaty), as an interchangeable biosimilar to Humira.
Fierce Pharma11d
After Hetlioz's rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use
After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...
Contract Pharma12d
FDA Approves argenx’s VYVGART Hytrulo Prefilled Syringe for Self-Injection
Argenx’s VYVGART Hytrulo prefilled syringe for self-injection has received FDA approval for the treatment of adult patients ...
Pharmabiz7d
US FDA designates Celltrion’s Yuflyma as an interchangeable biosimilar to Humira
US FDA designates Celltrion’s Yuflyma as an interchangeable biosimilar to Humira: Incheon, South Korea Wednesday, April 16, 2025, 16:00 Hrs [IST] Celltrion, Inc. announced that ...
Metastatic Melanoma Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
In January 2025, Melanoma Institute Australia announced a phase II, open label, randomised trial of ipilimumab and nivolumab ...
Tharimmune announces FDA feedback on TH104 NDA path
Tharimmune (THAR) announced in addition to developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with ...