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As the year comes to a close, we look at some of the FDA’s noteworthy new drug approvals, including two pricey gene therapies and other advancements for treatment of neurological conditions, such as Amyotrophic Lateral Sclerosis (ALS) and other rare diseases. Read More
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