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The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
English health authorities next month will decide whether to stop reimbursing 25 cancer drugs because they are too expensive, a decision that has riled manufacturers who believe it will restrict patient access to treatments. Read More
Genentech’s cancer drug Avastin won approval Friday to treat platinum-resistant, recurrent ovarian cancer in combination with chemotherapy, marking the eighth time the FDA has greenlighted the blockbuster product. Read More
The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the products. Read More
The FDA approved two sNDAs for Johnson & Johnson’s antipsychotic Invega Sustenna to treat patients with schizoaffective disorder, which will help the drugmaker offset lower sales of its neurological treatments due to generic competition. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More
Par Pharmaceutical said yesterday the FDA has approved its NDA for Vasostrict injection, making it the first product of its kind to win approval. Read More
A key Senate health panel will consider a bipartisan bill to hasten the development of Ebola drugs by including the disease under a lucrative voucher program. Read More
The European Medicines Agency has released an online tool designed to help manufacturers report and edit information on their marketed products, as required under the 2010 pharmacovigilance law. Read More