FDA
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
FEATURED STORIES
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.
A recent Phase II trial show Regeneron’s monoclonal antibody evinacumab significantly reduced fasting triglycerides in patients with severe hypertriglyceridemia.
Empaveli (pegcetacoplan) is the first and only targeted C3 therapy for the treatment of adults with PNH, the Waltham, Mass.-based company said in its announcement.
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
Clearance of the IND allows Samus to proceed with a Phase Ib trial to assess the safety, tolerability and pharmacokinetics of PU-AD in a small group of patients with recurrent malignant glioma.