gastroenterology

048 — Beqvez for Hemophilia B, Anktiva for Bladder Cancer, Pivya for UTI, Tovorafenib for Pediatric Low-Grade Glioma, Entyvio Maintenance for Crohn’s Disease, Alecensa for NSCLC, SPG601 for Fragile X Syndrome, Lumisight for Visualizing Breast Cancer

Beqvez for Hemophilia BThe FDA has approved fidanacogene elaparvovec-dzkt (Beqvez), a gene therapy, for adults with moderate to severe hemophilia B who meet certain criteria. Beqvez is a one-time treatment…

Continue Reading048 — Beqvez for Hemophilia B, Anktiva for Bladder Cancer, Pivya for UTI, Tovorafenib for Pediatric Low-Grade Glioma, Entyvio Maintenance for Crohn’s Disease, Alecensa for NSCLC, SPG601 for Fragile X Syndrome, Lumisight for Visualizing Breast Cancer

043 — Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC

Here is information on the latest US FDA approvals, the week of March 11 – March 15, 2024Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic…

Continue Reading043 — Liso-cel for CLL/SLL, Tislelizumab for Esophageal SCC, Resmetirom for NASH, Maralixibat for Cholestatic Pruritus, Guselkumab for UC

041 — Amivantamab for NSCLC, Drug-Coated Balloon for ISR, Ibrutinib Oral Suspension, Epcoritamab for Follicular Lymphoma, Govorestat for Galactosemia, Obeticholic Acid for PBC, Biktarvy for HIV, Roluperidone for Schizophrenia

Here is information on the latest US FDA approvals, the week of February 26 – March 1, 2024Amivantamab for NSCLCThe FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed)…

Continue Reading041 — Amivantamab for NSCLC, Drug-Coated Balloon for ISR, Ibrutinib Oral Suspension, Epcoritamab for Follicular Lymphoma, Govorestat for Galactosemia, Obeticholic Acid for PBC, Biktarvy for HIV, Roluperidone for Schizophrenia

039 — Lifileucel for Melanoma, Iloprost Injection for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide Oral Suspension for EOE, TriClip® for Tricuspid Regurgitation, ACE2016 for Solid Tumors, Human Acellular Vessel (HAV) for Vascular Trauma

00:00:00 Here is information on the latest US FDA approvals, the week of February 12 – February 16, 2024 Amtagvi for Melanoma The FDA has granted accelerated approval of lifileucel…

Continue Reading039 — Lifileucel for Melanoma, Iloprost Injection for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide Oral Suspension for EOE, TriClip® for Tricuspid Regurgitation, ACE2016 for Solid Tumors, Human Acellular Vessel (HAV) for Vascular Trauma

033 — FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals

No approvals this week, but I’ll talk about a couple of upcoming things that may be of interest. FDA approves first state request to import drugs from Canada and 5 upcoming…

Continue Reading033 — FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals

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

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