Keyword: Food and Drug Administration (FDA)
Merck has a shot at becoming the first company to receive clearance to sell a vaccine against the virus in the U.S.
In a 7-2 vote, an FDA panel backed Aimmune’s peanut allergy treatment for approval. It desensitizes patients with increasing doses of peanut protein.
Amgen posted what appeared to be an innocuous update about it drug Kyprolis and other pipeline assets, but a deeper read turned up a nasty surprise.
In documents, the FDA stressed the difference between allergic reactions to the treatment and allergic reactions due to accidental exposure to peanuts.
After steering Spark's Luxturna through FDA approval and launch, COO John Furey is heading Imvax, which is developing a brain cancer vaccine.
Axonics Modulation Technologies has received FDA approval for its rechargeable neuromodulation implant to treat bowel dysfunction.
Join us for this webinar as we bring together a panel of industry experts to discuss the changing landscape of biosimilar development and how it will affect pricing in the future.
Two dose levels of Concert's alopecia drug beat placebo in phase 2, teeing it up to enter phase 3 in 2020.
Concept Medical received an FDA breakthrough designation for its balloon designed to open a collapsed access vessel used during dialysis.
After years sterilization issues, the FDA is urging facilities to move to duodenoscopes with disposable components to reduce infection risks.