The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.  https://www.biospace.com/article/fda-approves-pfizer-s-talzenna-for-breast-cancer/ Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. https://www.biospace.com/article/amidst-strong-quarterly-growth-novartis-receives-fda-complete-response-letter-for-canakinumab/ Ocular[…]

The US FDA gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi (inotersen), a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi was previously green-lit in Canada and the European Union.  https://www.biospace.com/article/akcea-therapeutics-and-ionis-pharmaceuticals-snag-fda-approval-for-tegsedi/ The FDA has approved Leadiant Biosciences’ Revcovi (elapegademase-lvlr) for the treatment of adults and children with[…]

Verastem announced that the U.S. FDA has approved COPIKTRA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. https://www.marketwatch.com/press-release/verastem-oncology-receives-fda-approval-of-copiktratm-duvelisib-capsules-2018-09-24 Eli Lilly announced that the FDA has approved Emgality (galcanezumab-gnlm 120 mg injection) for the preventive treatment of migraine in adults. https://www.nasdaq.com/article/fda-approves-lillys-emgality-for-preventive-treatment-of-migraine-in-adults-20180927-01236 Pfizer[…]

The US FDA approved AstraZenea’s Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia.  https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-lumoxiti-moxetumomab-pasudotox-tdfk-for-certain-patients-with-relapsed-or-refractory-hairy-cell-leukaemia.html   Amryt announced that the FDA has granted IND clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis[…]

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[…]