The FDA has sent AstraZeneca a Complete Response Letter (CRL) over its supplemental Biologics License Application (sBLA) for the company’s blockbuster Fasenra (benralizumab), as a treatment for chronic rhinosinusitis with…
Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain…
Nektar Therapeutics’ experimental immunotherapy bempegaldesleukin paired with Bristol Myers Squibb’s (BMS) blockbuster checkpoint inhibitor, Opdivo (nivolumab), did not shrink tumors, slow the growth of tumors or prolong survival rates for…
Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Source: Drug Industry Daily
An FDA investigator observed that Belport, a drugmaker in Camarillo, Calif., doing business as Gingi-Pak, didn’t conduct microbiological testing of the water used to manufacture its drug products, among other…
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public…
AbbVie’s Qulipta (atogepant), already approved for prevention of episodic migraine, has released new phase 3 data that also support its preventive effect for chronic migraine. Source: Drug Industry Daily
Armed with positive phase 3 data, Venatorx Pharmaceuticals will ask regulators to approve its investigational combination antibiotic, cefepime-taniborbactam, as a treatment for complicated urinary tract infections (cUTI) in adults. Source:…
On Thursday night, the Senate was poised to pass the long-awaited $1.5 trillion, 2,700-page omnibus package to fund the federal government for fiscal year 2022 — five months after FY22…
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and…