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Insights+: The US FDA New Drug Approvals in 2018

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Insights+: The US FDA New Drug Approvals in 2018

1. Janssen's Erleada (apalutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Published: 14 Feb,2018 | Tags: Janssen, Erleada, apalutamide, Receives, FDA, Approval, Non-Metastatic Castration-Resistant Prostate Cancer, NM-CRPC

2. Helsinn's (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced Nausea and Vomiting (CINV)

Published: 14 Feb,2018 | Tags: Helsins, fosnetupitant + palonosetron, Receives, FDA, Approval, Managing Chemotherapy-Induced Nausea and Vomiting, CINV

3. Servier's Asparlas (calaspargase pegol-mknl) Receives FDA's Approval for Acute Lymphoblastic Leukemia (ALL)

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

5. Rigel Pharmaceuticals Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for Chronic Immune Thrombocytopenia (ITP) in Adults

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

9. Medicines Development for Global Health's (MDGH) Moxidectin Receives FDA Approval for Onchocerciasis (River Blindness)

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

12. Agios Pharmaceuticals Tibsovo (ivosidenib) Receives Approval For R/R Acute Myeloid Leukemia (AML) and IDH1 Mutation

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

17. Therapeutics MD's Annovera (Segesterone Acetate/Ethinyl Estradiol) Receives FDA Approval for the Prevention of Pregnancy

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

20. Biocodex's Diacomit (stiripentol) Receives FDA Approval for Seizures Associated with Dravet Syndrome (DS) in Patients Aged 2 Years or Older

Published: 23 Aug,2018 | Tags: Biocodex, Diacomit, stiripentol, Receives, FDA, Approval, Seizures, Associated, Dravet Syndrome, DS, Patients, Aged 2 Years ,Older

21.Shire's Takhzyro (lanadelumab-flyo) Receives FDA Approval Novel Hereditary Angioedema (HAE) in Age =12yrs

Published: 24 Aug,2018 | Tags: Shire, Takhzyro, lanadelumab-flyo, Receives, FDA, Approval, Novel, Hereditary Angioedema, HAE, Age, =12yrs

22. Lilly Receives FDA Approval for Emgality (galcanezumab-gnlm) for Preventive Treatment of Migraine in Adults

Published: 27 Aug,2018 | Tags: Eli Lilly, Receives, FDA, Approval, Emgality, galcanezumab-gnlm, Preventive, Treatment, Migraine, Adults

23. Tetraphase Pharmaceuticals Xerava (eravacycline) Receives FDA's Approval for Complicated Intra-Abdominal Infections (CIAI)

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

25. AstraZeneca's Lumoxiti Receives FDA approval for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients

Published: 14 Sep,2018 | Tags: AstraZeneca, Lumoxiti, Receives, FDA, Approval, for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients

26. Teva's Receives FDA Approval for the Treatment of Migraine in Adults with Monthly and Quarterly Dosing

Published: 17 Sep,2018 | Tags: Teva, Receives, FDA, Approval, Treatment, Migraine, Adults, Monthly, Quarterly Dosing

27. Verastem Oncology's Copiktra (duvelisib) Receives FDA Approval for r/r 2L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Published: 24 Sep,2018 | Tags: Verastem Oncology, Copiktra, duvelisib, Receives, FDA, Approval, R/R, 2L+, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, CLL

28. Pfizer's Vizimpro (Dacomitinib) Receives the US FDA Approval for 1L Treatment of mNSCLC with Epidermal Growth Factor Receptor (EGFR)

Published: 27 Sep,2018 | Tags: Pfizer, Vizimpro, Dacomitinib, Receives, the US FDA, Approval, 1L, Treatment, mNSCLC, Epidermal Growth Factor Receptor,EGFR

29. Sanofi's Libtayo Receives the US FDA approval for Metastatic Cutaneous Squamous Cell Carcinoma (mCSCC)

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

31. Paratek Pharmaceuticals' Nuzyra (omadacycline) Receives FDA Approval for Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI) in Adults

Published: 05 Oct,2018 | Tags: Paratek Pharmaceuticals, Nuzyra, omadacycline, Receives, FDA, Approval, Community-Acquired Bacterial Pneumonia, CABP, Acute Skin Skin Structure Infections,ABSSSI, Adult

32. Ionis Tegsedi (inotersen) Receives FDA Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

Published: 05 Oct,2018 | Tags: Ionis, Tegsedi, inotersen, Receives, FDA, Approval, Polyneuropathy, Hereditary Transthyretin-Mediated Amyloidosis, Adults

 33. Leadiant Biosciences Revcovi's (elapegademase-lvlr) Receives FDA Approval for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID) in Pediatric and Adult Patients

Published: 05 Oct,2018 | Tags: Leadiant Biosciences, Revcovi, (elapegademase-lvlr), Receives, FDA, Approval, Adenosine, Deaminase Severe Combined Immune Deficiency, (ADA-SCID), Pediatric, Adult, Patients

34. Eli Lilly's Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active Rheumatoid Arthritis (RA) in Adults

Published: 08 Oct,2018 | Tags: Eli Lilly, Olumiant, baricitinib, Receives, FDA, Approval, Moderately-to-Severely, Active, Rheumatoid Arthritis, RA, Adult

35. AbbVie's Orilissa (elagolix) Receives Health Canada Approval to Treat Moderate-to-Severe Pain Associated with Endometriosis

Published: 08 Oct,2018 | Tags: AbbVie, Orilissa (elagolix) Receives FDA’s 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

37. Pfizer's Daurismo (glasdegib) Receives FDA Approval for Adults with Newly-Diagnosed Acute Myeloid Leukemia (AML)

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.

40. Sobi’s Gamifant (emapalumab) Receives FDA Approval for Primary Haemophagocytic Lymphohistiocytosis (HLH

Published: 10 Nov,2018 | Tags: Sobi, Gamifant, emapalumab, Receives, FDA, Approval, Primary Haemophagocytic Lymphohistiocytosis, HLH

41. Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

Published: 30 Nov,2018 | Tags: Astellas, Xospata, gilteritinib, Receives, FDA ‘s, Approval, Treatment, Relapsed/Refactory Acute Myeloid Leukemia, (AML), Adults

42. Pfizer’s Lorbrena (lorlatinib) Receives FDA Approval for Patients with 1L ALK- Positive Metastatic NSCL

Published: 20 Nov,2018 | Tags: Pfizer, Lorbrena,lorlatinib, Receives, FDA, Approval, Patients, 1L, ALK, Positive, Metastatic, NSCLC

43. Shire’s Motegrity (prucalopride) Receives FDA Approval for Chronic Idiopathic Constipation (CIC) in Adults

Published: 17 Dec,2018 | Tags: Shire, Motegrity, prucalopride, Receives, FDA, Approval, Chronic Idiopathic Constipation, CIC, Adults

44. Alexion’s Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval for Paroxysmal Nocturnal Hemoglobinuria (PNH) in Adult

Published: 27 Dec,2018 | Tags: Alexion, Ultomiris, Ravulizumab-Cwvz, Receives, FDA, Approval, Paroxysmal Nocturnal Hemoglobinuria, PNH, Adults

45. FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy

Published: 31 Dec,2018 | Tags: FDA, Approves, Elzonris, tagraxofusp, First, Treatment, Blastic Plasmacytoid Dendritic Cell Neoplasm, First, CD123-Targeted, Therapy


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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