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Drugmakers spent more than $68 billion for the top acquisitions in 2022 and the biggest buyout by far was Amgen’s, announced just weeks before the year’s end. Read More
Ipsen Biopharmaceuticals has received a Complete Response Letter (CRL) from the FDA for palovarotene, the company’s investigational treatment for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP). Read More
The FDA issued a five-observation Form 483 to Tropical Seas’ over-the-counter drug manufacturing facility in Holly Hill, Fla., for inadequate testing and equipment maintenance, among other lapses observed in a July 11-15 inspection — including several repeat observations from a 2019 warning letter. Read More
An over-the-counter homeopathic anti-snoring nasal spray manufactured by Green Pharmaceuticals contained “gross microbial contamination,” including large numbers of the aerobic bacteria Providencia rettgeri, as well as yeast and mold, the FDA said in a warning letter to the company. Read More
The FDA handed Granules Pharmaceuticals’ Chantilly, Va., drug manufacturing facility a six-observation Form 483 for deficient quality control procedures and other production lapses following a July 18 to July 22 inspection. Read More
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the compound a priority review. Read More