US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), the agencies came to together to warn four online networks operating 10 websites that illegally market unapproved and misbranded versions of opioids. FDA notes that the illegal online pharmacies may put people in danger on the grounds that... Read More
The U.S.Food and Drug Administration has affirmed rituximab (Rituxan, Genentech) for the treatment of granulomatosis with polyangiitis (GPA, or also called as Wegener’s) and microscopic polyangiitis (MPA) in children 2 years of age and older combination with glucocorticoids. “It is the first approved treatment for children with these rare... Read More
The U.S. Food and Drug Administration today extended the endorsement of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week term for the treatment of grown-ups and kids ages 12 years and more seasoned or weighing at any rate 99 pounds who have ceaseless hepatitis C infection (HCV) genotype 1,... Read More
The approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults (18 years of age and older) determined to be at high risk for smallpox or monkeypox infection was announced by the U.S. Food and Drug Administration. For the prevention... Read More
The US Food and Drug Administration (FDA) is warning healthcare professionals and patients of a review of 14 bunches of ranitidine capsules appropriated by Sandoz Inc, the biosimilars and generics unit of Swiss pharma mammoth Novartis, used to decrease the amount of acids secreted by the stomach. This review... Read More
Merck’s revered checkpoint inhibitor Keytruda grabbed another administrative endorsement. The U.S. Nourishment and Drug Administration (FDA) affirmed Keytruda in blend with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma. Keytruda, an anti PD-1 treatment, and Lenvima, an oral kinase inhibitor, were approved for patients whose carcinoma... Read More
Salmonella bacteria were found by the U.S. Food and Drug Administration (USFDA) in three batches of MDH’s sambar masala. The USFDA said in a release that lot code 108, 47 and 48 are the three lots which have been manufactured by R-Pure Agro Specialities and were sold by House... Read More
Federal health officials have learned that Sanofi’s heartburn medication Zantac includes an impurity that could cause cancer, the U.S. Food and Drug Administration said Friday. The probe comes after Valisure, an online pharmacy company, said it alerted the FDA that it found NDMA in Zantac. The FDA said it... Read More
Juul Company was slammed by Federal health officials for illegally advertising its nicotine pods as a safer alternative to cigarettes, threatening to fine or even seize the company‟s products if it doesn‟t correct its marketing. A warning letter was sent to the CEO Kevin Burns by the Food and... Read More
The US Food and Drug Administration (FDA) warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results. In a securities disclosure issued on 2 July, Strides... Read More
A warning letter was issued by the U.S. FDA to Foshan Jinxiong Technology, a contract manufacturer of over-the-counter drugs for children, citing four violations related to quality control. After the inception last August, the warning letter to the Chinese drug maker’s facility in the city of Foshan arrived. Banning... Read More
For violation of current good manufacturing practice norms, including failure to investigate the presence of a carcinogen in a solvent USFDA has pulled up Lantech Pharmaceuticals at its Andhra Pradesh-based manufacturing plant. At the company’s Ranastalam (Srikakulam district) based plant, the inspectors found significant deviations from standard manufacturing, said... Read More
US public health officials warned who aren’t already smokers to avoid e-cigarettes and other vaping devices after a mysterious outbreak of a serious lung disease which has sickened 215 individuals across 25 states and been connected to at least one death. The US Centers for Disease Control and Prevention... Read More
AbbVie’s new treatment for rheumatoid arthritis was approved by the U.S. Food and Drug Administration. It is a win for the drug maker seeking to widen its portfolio as its blockbuster flagship therapy Humira faces competition. The drug, Rinvoq is additionally called as upadacitinib and it has a place... Read More
A complete response letter (CRL) was issued by the US Food and Drug Administration (US FDA) for the New Drug Application (NDA) for insulin glargine filed by partner Mylan, said Biocon. In response to the observations made at the conclusion of the pre-approval inspection of the insulin manufacturing facility... Read More