rare-diseases

029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device

Here is information on the latest US FDA approvals, the week of December 2 -  December 8, 2023 Iptacopan (Fabhalta) for PNH The FDA has approved iptacopan (Fabhalta) as the first…

Continue Reading029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device

026 — Tirzepatide for Obesity, Ixchiq Chikungunya Vaccine, fruquintinib for mCRC, Adzynma (ADAMTS13, recombinant-krhn) for cTTP

Here is information on the latest US FDA approvals, the week of November 6 -  November 10, 2023Tirzepatide (Zepbound) for Adults With ObesityThe FDA has approved Zepbound (tirzepatide) injection for…

Continue Reading026 — Tirzepatide for Obesity, Ixchiq Chikungunya Vaccine, fruquintinib for mCRC, Adzynma (ADAMTS13, recombinant-krhn) for cTTP

025 — Pembrolizumab, Secukinumab, Ustekinumab biosimilar, Vonoprazan, Abatacept, Exa-cel

Pembrolizumab (Keytruda) for Metastatic Biliary Tract CancerThe FDA has granted approval for pembrolizumab (Keytruda) in combination with gemcitabine and cisplatin for the treatment of patients diagnosed with locally advanced unresectable…

Continue Reading025 — Pembrolizumab, Secukinumab, Ustekinumab biosimilar, Vonoprazan, Abatacept, Exa-cel

024 — Loqtorzi, Vabysmo, Omvoh, Vamorolone, Tibsovo, FluMist

Here is information on the latest US FDA approvals, the week of October  23 -  October 27, 2023 Loqtorzi (toripalimab-tpzi) for Nasopharyngeal Carcinoma The FDA has approved Loqtorzi (toripalimab-tpzi), a…

Continue Reading024 — Loqtorzi, Vabysmo, Omvoh, Vamorolone, Tibsovo, FluMist

023 — Bimzelx (bimekizumab); Keytruda (Pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); Cabtreo (IDP-126); Penbraya; Voxzogo (vosoritide); Qlosi (pilocarpine); Maxigesic IV (paracetomol/ibuprofen); Xphozah (tenapanor); Zymfentra (SC infliximab biosimilar)

Here is information on the latest US FDA approvals, the week of October  16 -  October 20, 2023 Bimzelx (bimekizumab) for Moderate-to-Severe Plaque Psoriasis The FDA has approved BIMZELX® (bimekizumab-bkzx)…

Continue Reading023 — Bimzelx (bimekizumab); Keytruda (Pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); Cabtreo (IDP-126); Penbraya; Voxzogo (vosoritide); Qlosi (pilocarpine); Maxigesic IV (paracetomol/ibuprofen); Xphozah (tenapanor); Zymfentra (SC infliximab biosimilar)

022 — Velsipity (Etrasimod) for UC; Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC; Patisiran in ATTR amyloidosis; Digital Health Advisory Committee

Here is information on the latest US FDA approvals, the week of October  9 –  October 13, 2023Velsipity (Etrasimod) for UCThe FDA has approved Velsipity (etrasimod) for treating moderate to…

Continue Reading022 — Velsipity (Etrasimod) for UC; Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC; Patisiran in ATTR amyloidosis; Digital Health Advisory Committee

021 — Novavax COVID Vaccine, Rivfloza (Nedosiran) for Primary Hyperoxaluria, Intravenous Cosentyx, Abrilada Adalimumab Biosimilar, Large Volume On-Body Injector

 Here is information on the latest US FDA approvals, the week of October  2 –  October 6, 2023 Novavax COVID VaccineThe updated COVID-19 vaccine made by Novavax is now approved for…

Continue Reading021 — Novavax COVID Vaccine, Rivfloza (Nedosiran) for Primary Hyperoxaluria, Intravenous Cosentyx, Abrilada Adalimumab Biosimilar, Large Volume On-Body Injector

020 — Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous Entyvio, NurOwn in ALS

Here is information on the latest US FDA approvals, the week of September 25 –  September 29, 2023Ryzumvi (Phentolamine Ophthalmic Solution) for Dilated PupilsThe FDA has approved Ryzumvi (phentolamine ophthalmic…

Continue Reading020 — Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous Entyvio, NurOwn in ALS

018 — Ojjaara for Anemia in Myelofibrosis, Resmetirom for NASH, COVID-19 Vaccine Update, Phenylephrine, Patisiran in ATTR-CM

Here is information on the latest US FDA approvals, the week of September 11 –  September 15, 2023.FDA Approves Ojjaara (Momelotinib) for Anemia in MyelofibrosisThe FDA has approved Ojjaara (momelotinib)…

Continue Reading018 — Ojjaara for Anemia in Myelofibrosis, Resmetirom for NASH, COVID-19 Vaccine Update, Phenylephrine, Patisiran in ATTR-CM

017 — Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH

Check out our free downloads: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical…

Continue Reading017 — Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH