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Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More
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
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. 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
Eli Lilly Thursday scored its second court victory in less than a week and third overall in lawsuits against its blockbuster antidepressant Cymbalta. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. 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
A Houston, Texas, API and finished drugmaker received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More