On Monday, February 13, 2023, Natco Pharma announced that it had submitted a new application to the US health regulator for marketing authorization of the generic version of Olaparib tablets, which are used to treat some types of ovarian, breast, pancreatic, and prostate cancer. The generic version of AstraZeneca’s Olaparib tablets in strengths of 100mg […]
Continue Reading
On February 8, 2023, the US Food and Drug Administration (FDA) informed Blueprint Medicines Corporation that the Phase 1/2 VELA trial of BLU-222 had been placed on partial clinical hold due to the presence of visual adverse events (AEs) in a small number of patients. According to the study, the drug is being administered to […]
Continue Reading
Aurobindo Pharma’s, Aurolife Pharma LLC, has been granted final approval to manufacture and market Diclofenac Sodium Topical Solution by the US Food and Drug Administration (FDA). Horizon Therapeutics Ireland DAC (Horizon)’s Pennsaid Topical Solution, a reference listed drug (RLD), and the approved product are bioequivalent and therapeutically comparable. Osteoarthritis can be treated with Diclofenac Sodium […]
Continue Reading
An eye drop made in India has been linked to the spread of a drug-resistant bacteria, resulting in infections, blindness, and one death in at least 55 patients, according to the US Food and Drug Administration (FDA). The US FDA said that India’s Global Pharma Healthcare Pvt Ltd’s ‘Artificial Tears’ eye drop could be contaminated […]
Continue Reading
GSK’s daprodustat, which is sold under the brand name Jesduvroq, has been granted class-first approval following two previous FDA rejections for oral anemia medications in the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class. The drug is specifically approved for the treatment of chronic kidney disease patients with anemia who have been on dialysis for […]
Continue Reading
The major pharmaceutical company made the announcement that its new drug application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide (DETAF) tablets had received preliminary approval from the US Food and Drug Administration (USFDA). DETAF tablets were tentatively approved by the US Food and Drug Administration as part of the President’s Emergency Plan to Fight AIDS (PEPFAR). […]
Continue Reading
Loxo@Lilly, Eli Lilly and Company’s oncology division, has received US FDA approval for Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Based on the response rate from the […]
Continue Reading
Because it is not anticipated that AstraZeneca’s COVID-19 antibody cocktail Evusheld will neutralize the Omicron subvariant’s XBB.1.5 subvariant, the U.S. health regulator has revoked the treatment’s emergency-use authorization. Evusheld’s use had been restricted earlier this month for the same reason by the Food and Drug Administration (FDA), and the agency’s announcement on Thursday sent U.S. […]
Continue Reading
The US Food and Drug Administration (FDA) has proposed that COVID-19 vaccinations more like the flu shot every year. On Monday, January 23, 2023, the US Food and Drug Administration (FDA) of the United States announced a simplified plan for future vaccination efforts that would enable the majority of adults and children to receive a […]
Continue Reading
Alembic Pharmaceuticals gained 1.19 percent to Rs 559 following the tentative approval of its Acalabrutinib capsules from the US Food and Drug Administration (USFDA). Calquence capsules, 100 mg, from AstraZeneca UK (AstraZeneca), the reference listed drug product (RLD), is the therapeutic equivalent of the approved ANDA. Acalabrutinib capsules are indicated for the treatment of adult […]
Continue Reading