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The FDA issued a warning letter to an over-the-counter (OTC) drug manufacturing facility in South Korea following a review of records that raised quality concerns about an acne treatment. Read More
The FDA has placed clinical holds on two drugs that use the transferrin receptor to gain access to their sites of action, raising concerns about the entire approach. Read More
Bristol Myers Squibb (BMS) subsidiary Juno Therapeutics has lost a bid to persuade a U.S. appeals court to overturn its own decision tossing out a $1.2 billion patent verdict that Juno won against Gilead Sciences subsidiary Kite Pharma. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
The EMA previously recommended adding transverse myelitis to the list of possible side effects linked with Johnson & Johnson’s COVID-19 vaccine. Read More
Terlipressin products are authorized in several EU countries to treat increased pressure in central veins that can cause kidney problems in people with hepatorenal syndrome. Read More
All is well between Eli Lilly and the FDA after the agency’s Office of Prescription Drug Promotion (OPDP) admonished the drugmaker for not submitting two direct-to-consumer TV advertisements for its migraine drug Emgality (galcanezumab) to FDA for consideration before the ads aired. Read More
The European Commission has laid out its regulations for selecting EU member states to evaluate suspected unexpected serious adverse reactions (SUSARs) that occur in clinical trials. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand the drug’s Emergency Use Authorization (EUA) to include it. Read More
As the Omicron variant rages, Peter Marks, the FDA’s top vaccine regulator, said that getting a booster dose earlier than six months after initial doses may be the best way to guard against the ubiquitous variant. Read More