Insights+: The US FDA New Drug Approvals in 2018
Published: 14 Feb,2018 | Tags: Janssen, Erleada, apalutamide, Receives, FDA, Approval, Non-Metastatic Castration-Resistant Prostate Cancer, NM-CRPC
Published: 14 Feb,2018 | Tags: Helsins, fosnetupitant + palonosetron, Receives, FDA, Approval, Managing Chemotherapy-Induced Nausea and Vomiting, CINV
Published: 01 Mar,2018 | Tags: Servier, Asparlas, calaspargase pegol-mknl, Receives, FDA, Approval, Acute Lymphoblastic Leukemia, ALL
4. TaiMed Biologics Trogarzo (ibalizumab-uiyk) Receives Approval for Multidrug Resistant (MDR)-HIV
Published: 06 Mar,2018 | Tags: TaiMed Biologics, Trogarzo, ibalizumab-uiyk, Receives, Approval, Multidrug Resistant, MDR-H
Published: 06 Mar,2018 | Tags: Rigel Pharmaceuticals, Tavalisse, fostamatinib disodium hexahydrate, Receives, FDA, Approval, Chronic Immune Thrombocytopenia, ITP, Adults
6. Amgen's Aimovig (erenumab-aooe) Receives FDA's Approval for Prevention of Migraine in Adults
Published: 17 May,2018 | Tags: Amgen, Aimovig, erenumab-aooe, Receives, FDA, Approval, Prevention, Migraine, Adults
7. AstraZeneca's Lokelma Receives FDA's Approval for Patients with Hyperkalaemia in Adults
Published: 18 May,2018 | Tags: AstraZeneca, Lokelma, Receives, FDA, Approval, Patients, Hyperkalaemia, Adults
8. BioMarin's Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in Adults
Published: 24 May,2018 | Tags: BioMarin, Palynziq, pegvaliase-pqpz, Receives, FDA, Approval, Phenylketonuria, PKU, Adults
Published: 13 Jun,2018 | Tags: Medicines Development for Global Health, MDGH, Moxidectin, Receives, FDA, Approval, Onchocerciasis, River Blindness
10. GSK's Krintafel (tafenoquine) Receives FDA Approval Preventing the Relapse of P.vivax Malaria
Published: 20 Jun,2018 | Tags: GSK, Krintafel, tafenoquine, Received, FDA, approval, Preventing, Relapse , P.vivax Malaria
11. GW Pharmaceuticals Epidiolex (cannabidiol) Receives FDA Approval for Epilepsy for 2yrs. or older
Published: 25 Jun,2018 | Tags: GW Pharmaceuticals, Epidiolex, cannabidiol, Receives, FDA, Approval, Epilepsy, 2yrs, older
Published: 26 Jun,2018 | Tags: Agios Pharmaceuticals, Tibsovo, ivosidenib, Receives, Approval, R/R, Acute Myeloid Leukemia, AML, IDH1 Mutation
13. Achaogen's Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract Infection (cUTI)
Published: 26 Jun,2018 | Tags: Achaogen, Zemdri, plazomicin, Receives, FDA, Approval, Complicated Urinary Tract Infection, cUTI
14. SIGA Technologies TPOXX (tecovirimat) Receives FDA Approval for Smallpox
Published: 26 Jun,2018 | Tags: SIGA Technologies, TPOXX, tecovirimat, Receives, FDA, Approval, Smallpox
15. Shionogi's Mulpleta (lusutrombopag) Receives FDA Approval for Chronic Liver Patients in Adults
Published: 31 July,2018 | Tags: Shionogi, Mulpleta, lusutrombopag, Receives, FDA, Approval, Chronic Liver, Patients, Adults
16. FDA approves IV Poteligeo for Treating Two Rare types of Cutaneous T cell lymphoma (CTCL)
Published: 08 Aug,2018 | Tags: FDA, approves, IV, Poteligeo, Treating, Two, Rare, types, Cutaneous, T cell, lymphoma, CTCL
Published: 10 Aug,2018 | Tags: Therapeutics MD, Annovera, Segesterone Acetate/Ethinyl Estradiol, Receives, FDA, Approval, Prevention, Pregnancy
18. Amicus Therapeutics Galafold (migalastat) Receives FDA Approval for Fabry Disease in Adult Patient
Published: 10 Aug,2018 | Tags: Amicus Therapeutics, Galafold, migalastat, Receives, FDA, Approval, Fabry Disease, Adult Patients
19. FDA Approves Onpattro, a Novel RNAi Therapeutic to Treat Polyneuropathy in Adults
Published: 13 Aug,2018 | Tags: FDA, Approves, Onpattro, Novel, RNAi, Therapeutic, Treat, Polyneuropathy, Adults
Published: 23 Aug,2018 | Tags: Biocodex, Diacomit, stiripentol, Receives, FDA, Approval, Seizures, Associated, Dravet Syndrome, DS, Patients, Aged 2 Years ,Older
Published: 24 Aug,2018 | Tags: Shire, Takhzyro, lanadelumab-flyo, Receives, FDA, Approval, Novel, Hereditary Angioedema, HAE, Age, =12yrs
Published: 27 Aug,2018 | Tags: Eli Lilly, Receives, FDA, Approval, Emgality, galcanezumab-gnlm, Preventive, Treatment, Migraine, Adults
Published: 27 Aug,2018 | Tags: Tetraphase Pharmaceuticals, Xerava, eravacycline , Receives, FDA, Approval, Complicated Intra-Abdominal Infections, CIAI
24. Merck's Pifeltro (doravirine) Receives FDA Approval for Patients with HIV-1 in Appropriate Patients
Published: 14 Sep,2018 | Tags: Merck, Pifeltro, doravirine, Receives, FDA, Approval, Patients, HIV-1, Appropriate Patients
Published: 14 Sep,2018 | Tags: AstraZeneca, Lumoxiti, Receives, FDA, Approval, for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients
Published: 17 Sep,2018 | Tags: Teva, Receives, FDA, Approval, Treatment, Migraine, Adults, Monthly, Quarterly Dosing
Published: 24 Sep,2018 | Tags: Verastem Oncology, Copiktra, duvelisib, Receives, FDA, Approval, R/R, 2L+, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, CLL
Published: 27 Sep,2018 | Tags: Pfizer, Vizimpro, Dacomitinib, Receives, the US FDA, Approval, 1L, Treatment, mNSCLC, Epidermal Growth Factor Receptor,EGFR
Published: 28 Sep,2018 | Tags: Sanofi, Libtayo, Receives, the US FDA, Approval, Metastatic Cutaneous Squamous Cell Carcinoma, mCSCC
30. Paratek's Seysara (sarecycline) Receives FDA's Approval for Treatment of Moderate to Severe Acne
Published: 02 Oct,2018 | Tags: Paratek, Seysara, sarecycline, Receives, FDA, Approval, Treatment, Moderate to Severe, Acne
Published: 05 Oct,2018 | Tags: Paratek Pharmaceuticals, Nuzyra, omadacycline, Receives, FDA, Approval, Community-Acquired Bacterial Pneumonia, CABP, Acute Skin Skin Structure Infections,ABSSSI, Adult
Published: 05 Oct,2018 | Tags: Ionis, Tegsedi, inotersen, Receives, FDA, Approval, Polyneuropathy, Hereditary Transthyretin-Mediated Amyloidosis, Adults
Published: 05 Oct,2018 | Tags: Leadiant Biosciences, Revcovi, (elapegademase-lvlr), Receives, FDA, Approval, Adenosine, Deaminase Severe Combined Immune Deficiency, (ADA-SCID), Pediatric, Adult, Patients
Published: 08 Oct,2018 | Tags: Eli Lilly, Olumiant, baricitinib, Receives, FDA, Approval, Moderately-to-Severely, Active, Rheumatoid Arthritis, RA, Adult
Published: 08 Oct,2018 | Tags: AbbVie, Orilissa (elagolix) Receives FDAs Approval for Moderate-to-Severe Pain Associated with Endometriosis
36. Pfizer's Talzenna (talazoparib) Receives FDA Approval for BRCA-Mutated, HER2-Negative LA or MBC
Published: 11 Oct,2018 | Tags: Pfizer, Talzenna, (talazoparib), Receives, FDA ,Approval, BRCA-Mutated, HER2-Negative, LA , MBC
Published: 11 Oct,2018 | Tags: Pfizer, Daurismo, glasdegib, Receives, FDA, Approval, Adults, Newly-Diagnosed, Acute Myeloid Leukemia, AML
38. Catalyst's Firdapse (amifampridine) Receives FDA's Approval for Lambert-Eaton Myasthenic Syndrome
Published: 20 Oct,2018 | Tags: Catalyst, Firdapse, amifampridine, Receives, FDA, Approval, Lambert-Eaton Myasthenic Syndrome
39. Roche’s Xofluza (baloxavir marboxil) Receives FDA Approval for Influenza in Patients Aged ≥12 yrs.
Published: 25 Oct,2018 | Tags: Roche, Xofluza, baloxavir marboxil, Receives, FDA, Approval, Influenza, Patients, Aged, ≥12 yrs.
Published: 10 Nov,2018 | Tags: Sobi, Gamifant, emapalumab, Receives, FDA, Approval, Primary Haemophagocytic Lymphohistiocytosis, HLH
Published: 30 Nov,2018 | Tags: Astellas, Xospata, gilteritinib, Receives, FDA ‘s, Approval, Treatment, Relapsed/Refactory Acute Myeloid Leukemia, (AML), Adults
Published: 20 Nov,2018 | Tags: Pfizer, Lorbrena,lorlatinib, Receives, FDA, Approval, Patients, 1L, ALK, Positive, Metastatic, NSCLC
Published: 17 Dec,2018 | Tags: Shire, Motegrity, prucalopride, Receives, FDA, Approval, Chronic Idiopathic Constipation, CIC, Adults
Published: 27 Dec,2018 | Tags: Alexion, Ultomiris, Ravulizumab-Cwvz, Receives, FDA, Approval, Paroxysmal Nocturnal Hemoglobinuria, PNH, Adults
Published: 31 Dec,2018 | Tags: FDA, Approves, Elzonris, tagraxofusp, First, Treatment, Blastic Plasmacytoid Dendritic Cell Neoplasm, First, CD123-Targeted, Therapy
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