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The number of gene, cell and RNA therapies continue to grow rapidly with almost 3,500 treatments in either the preclinical or clinical testing phases, a new report says. Read More
The FDA and industry groups have laid out their initial proposals in several negotiation meetings ahead of the third authorization of the Biosimilar User Fee Act (BsUFA) that will cover fiscal 2023 through 2027. Read More
The FDA has issued a complete response letter (CRL) to LEO Pharma, requesting additional information regarding a device component for the Danish drugmaker’s moderate-to-severe atopic dermatitis candidate tralokinumab. Read More
Worldwide drug spending — excluding spending on COVID-19 vaccines — is projected to increase by 3 percent to 6 percent at a compounded annual growth rate through 2025, climbing to $1.6 trillion, fueled primarily by oncology and immunology development, says a new report from IQVIA. Read More
The FDA has withdrawn a Trump era policy aimed at improving transparency by requiring the agency to publish more information on drug review timelines. Read More
The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. Read More
The FDA’s Oncologic Drugs Advisory Committee assembled yesterday for its third and final meeting this week to discuss accelerated approvals for cancer drugs that didn’t verify their benefit in confirmatory trials, advising the agency to withdraw indications for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) while defending another Keytruda indication. Read More