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Companies planning to market a botanical drug under an NDA must be able to prove the therapeutic consistency of the product, since the potential for variation is critical, the FDA says. Read More
Companies developing drugs for rare diseases that lack alternative treatments may be able to start clinical trials without the standard toxicology studies, provided they justify the approach, the FDA says. Read More
Boehringer Ingelheim is aiming to broaden its research into diabetes and other cardiometabolic diseases via a partnership with Circuit Therapeutics to develop novel drugs to treat obesity. Read More
The FDA has extended until Nov. 27 its deadline for deciding whether to approve Bristol-Myers Squibb’s sBLA for Opdivo in previously untreated advanced melanoma to allow the company to present additional data from a Phase 3 clinical trial. Read More
AbbVie said it will seek FDA approval later this year for its investigational leukemia treatment venetoclax, after the drug met its primary goal in a Phase 2 trial. Read More
Proteon Therapeutics has enrolled its first patient in a second Phase 3 clinical study evaluating vonapanitase as a guard against vascular access failure in hemodialysis patients. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More