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API manufacturer Jiangsu NHWA Pharmaceutical drew a warning letter from the FDA for inadequate laboratory protocols and investigations into foreign particles in batches of active ingredients, following an inspection of its Jiawang site in Xuzhou. Read More
Pharma companies that made and marketed Zantac (ranitidine) are facing lawsuits in California, Colorado and Pennsylvania alleging that they failed to disclose or investigate the drug’s dangers. Read More
Humana filed suit against Teva and 30 other generic drugmakers in a Pennsylvania federal court for allegedly conspiring to fix the prices of more than 100 generic drugs. Read More
Positron emission tomography (PET) drug manufacturer SOFIE drew a warning letter from the FDA for fungal contamination in ISO 5 areas at its facility in Sanford, Florida. Read More
Biogen has decided to renew its bid for FDA approval in early 2020 of its investigational anti-amyloid Alzheimer’s drug aducanumab after halting clinical trials earlier this year. Read More
The FDA has granted part of a citizen petition calling for a safety warning on certain dopamine agonist drugs on the risks of impulse-control disorders (ICD)s for patients taking the drugs for restless legs syndrome (RLS). Read More
The FDA outlined the manufacturing facility information that should be included in applications submitted to CDER and CBER in a final guidance released on Tuesday. Read More
On a party-line vote of 24 to 17, the House Committee on Ways and Means on Tuesday advanced House Speaker Nancy Pelosi’s drug pricing legislation, H.R. 3, to the house floor. Read More