article thumbnail

Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

article thumbnail

Likmez: First FDA-Approved Liquid Option of the Antibiotic Metronidazole

XTalks

Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Wainua (Eplontersen) Now FDA-Approved for Rare Disease ATTRv-PN

XTalks

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

article thumbnail

Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

XTalks

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Regarding the price of Filsuvez, it has not yet been publicly disclosed by the company.

article thumbnail

Konvomep Gets FDA Approval as a New Oral Liquid Formulation Option of Omeprazole

XTalks

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension). Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines.

article thumbnail

US FDA approves Takeda’s HyQvia to treat PI in children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

article thumbnail

Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma

Pharmaceutical Commerce

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.