Shire announced that following priority review, the U.S. FDA has approved TAKHZYRO™ (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of swelling in various parts of the body. http://globenewswire.com/news-release/2018/08/23/1556201/0/en/Shire-Announces-FDA-Approval-of-TAKHZYRO-lanadelumab-flyo-a-First-of-its-Kind-mAb-Preventive-Treatment-for-Hereditary-Angioedema.html[…]

Alnylam Pharmaceuticals announced that the US FDA approved ONPATTRO™ (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.  http://investors.alnylam.com/news-releases/news-release-details/alnylam-announces-first-ever-fda-approval-rnai-therapeutic The FDA approved Amicus Therapeutics’ Galafold, the first oral therapy to treat Fabry disease, a rare, sometimes fatal condition in which accumulation[…]

Agios Pharmaceuticals said the US FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year. https://www.biospace.com/article/agios-pharmaceuticals-scores-fda-approval-for-tibsovo-second-aml-drug-win-in-less-than-a-year/ SIGA Technologies announced that the FDA approved its filing for oral TPOXX (tecovirimat) as the first therapy with an indication specifically for the treatment of smallpox “to mitigate the[…]

Alkermes plc. announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) extended-release product for the treatment of schizophrenia in adults.  Aristada was initially approved by the FDA in 2015.  https://www.nasdaq.com/article/alkermes-aristada-initio-approved-by-fda-for-schizophrenia-cm987009 The FDA has approved Merz Pharma’s sBLA for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients.  https://www.thepharmaletter.com/article/fda-approves-neurotoxin-for-excessive-drooling-in-adults Mylan[…]

The FDA issued a Complete Response Letter for Valeant’s Duobrii, flagging questions related to the drug’s pharmacokinetics, according to a June 18 statement from the company. https://www.biopharmadive.com/news/valeant-hit-crl-fda-rejection-psoriasis-drug-duobrii/525923/ Shire announced that the FDA has approved a label expansion for CINRYZE® (C1 esterase inhibitor), making it available to help prevent angioedema attacks in children aged 6 years[…]