USFDA

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

Cytalux is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA® Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.

BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech’s fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer.

The U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism.  

Pfizer Inc announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

Zydus Cadila has received final approval from the USFDA to market Glycopyrrolate Injection in the strengths of 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-Dose Vials, (US RLD: Robinul). Glycopyrrolate is used before surgery to decrease the volume of secretions from mouth, lungs and stomach.

Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with cancer and infectious diseases, announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), to start clinical studies with the company’s novel drug candidate BAL0891 in cancer therapy. BAL0891 is a potential first-in-class small-molecule kinase inhibitor.

AbbVie announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.

Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.