Research updates in this edition include drug successes for multiple myeloma, COPD, breast cancer and weight loss as well as disappointments in drugs for colorectal and endometrial cancer as well…

Amazon was hit with its third FDA warning letter of the year last week, this time for selling unapproved and incorrectly labeled products that contain the active ingredient in erectile…

The FDA has issued a direct-to-final guidance on using benzene in drug manufacture and has revised a recently issued draft guidance on topical ophthalmic drug quality, an area in which…

Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile…

This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with…

Apple’s request earlier this week for an interim stay of federal orders to stop selling its watches is hardly an emergency, claims Masimo. Source: Drug Industry Daily

As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and…

The FDA delivered a couple of unwelcome holiday gifts to two hopeful sponsors in the form of Complete Response Letters (CRL) — one for Merck’s chronic cough drug gefapixant and…

As if lawsuits and plummeting stock prices from its faulty CPAP machines didn’t provide enough bad headlines, Philips now wants customers to pull the plug on one of its magnetic…

Bristol Myers Squibb’s (BMS) $14 billion acquisition of Karuna Therapeutics accelerates the company’s diversification into the neuroscience space with Karuna’s priority asset, KarXT (xanomeline-trospium), leading the way. Source: Drug Industry…