Science & Medicine

New FDA Approvals

In this podcast, which airs Monday through Friday, medical writer Dr. Emma Nichols discusses the latest happenings coming out of the US Food and Drug Administration (FDA).

Episodes

20 of 100 episodes

162 - elagolix for endometriosis pain; smartphone urinalysis; magnetic device system for guiding sentinel lymph node biopsies

July 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com AbbVi...

08:17Jul 26, 2018

161 – Ivosidenib for AML; Mobile Cardiac Rehabilitation System; AGN-241751 for MDD; Senseonics Implantable Glucose Sensor; Essure withdrawal

July 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com FDA a...

09:24Jul 23, 2018

160 - darunavir single tablet; pain relief study; Tau modifier gets orphan drug designation; IND for CARMA platform; CAM2038 for opioid use disorder; FDA's speedy oncology review pilot; empowering nonprescription drugs

July 19, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45...

14:43Jul 19, 2018

159 - First smallpox treatment; enzalutamide for nmCRPC; PCT assay expanded use; romosozumab for osteoporosis

July 16, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:38...

08:32Jul 16, 2018

158 - REC-994 for cerebral cavernous malformation; RD1 innovative device for wound management; FDA 510(k) clearance for device to monitor eyesight in AMD; low dose loteprednol; OBI-3424 for HCC; fluoroquinolones labeling; FDA Gene therapy guidance

July 12, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.co 0:35 R...

14:45Jul 12, 2018

157 - FDA clears adipose tissue system for surgical repair; IND application for BAY 1905254; ARISTADA® for schizophrenia; COM701, a first-in-class Immuno-oncology antibody

July 9, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49 L...

09:45Jul 9, 2018

156 – Approval of Braftovi for melanoma; Xyrem for narcolepsy; spinal fusion system for lordosis; new device for emphysema; a wipe for sweaty armpits; Aptos c-Myc drug off the hook

July 2, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:44 A...

11:58Jul 2, 2018

155 - cannabidiol of lennoxgastault syndrome; clearance of Access hsTnI assay; FRESCA CPAP system; FDA meeting announcement for Nutrition Innovation Strategy

June 28, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0.33...

09:47Jun 28, 2018

154 - first catheter-based systems for vascular access in hemodialysis; PCS499 in necrobiosis lipoidica; automated insulin delivery for younger patients; first implantable continuous glucose monitoring system.

June 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:44...

08:53Jun 25, 2018

153 - ACX-362E for CDI; Cosentyx and inhibition of joint damage progression; new assays from Grifols; personalized optimization of insulin pump therapy; FDA and drug shortages for critical products; FDA guidance on attacks on food supply

June 21, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:47...

11:03Jun 21, 2018

152 - Suboxone sublingual generics; Tibial Nerve Neuromodulator for overactive bladder; FDA statement of cultured" food products (eg, Memphis Meats); FDA on dietary fiber;

June 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45...

10:58Jun 18, 2018

151 - PU-H71 for myelofibrosis; RGX-111 for Mucopolysaccharidosis; Moxidectin For The Treatment Of River Blindness; Wearable Device to Treat Opioid Addiction; FDA Clearance For Thrombectomy Device

June 14, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:48...

15:58Jun 14, 2018

150 – Venetoclax for CLL; CK0801 for bone marrow failure; 3D printed all-titanium fusion devices; National Youth Tobacco Survey results

June 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:58...

09:29Jun 11, 2018

149 - Neulasta biosimilar; Leukine for acute radiation syndrome; priority review for Hemlibra; FDA Office of New Drug reorganization

June 7, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:50 F...

12:15Jun 7, 2018

148 - Right to try act; Xeljanz for ulcerative colitis; Baricitinib for RA; first artificial iris; AURA™ ICP Monitoring System; neuro stent device; NKTR-181 first in class opioid; Priority Review for antiepileptic drug FYCOMPA® (perampanel); TX-004HR:

June 1, 2018 0:54 Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act https://www.fda.gov/NewsEvent...

19:20Jun 1, 2018

147 - Crizotinib breakthrough therapy designation; certolizumab for moderate-to-severe plaque psoriasis; Zeto wireless EEG headset; larotrectinib in solid tumors; Raviten for intradialytic hypotension

May 30, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:01 P...

13:48May 30, 2018

146 – FDA approves first PKU treatment; AI for detecting wrist fractures; FDA action against OTC benzocaine teething products

May 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49 F...

10:14May 25, 2018

145 - Sotagliflozin for T1DM; DTRAX® Spinal System; denosumab for glucocorticoid-induced osteoporosis; avatrombopag for thrombocytopenia in CLD; stent retriever device for ischemic stroke; Restylane dermal filler for hands.

Wednesday, May 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals...

16:30May 23, 2018

144 - Aimovig for migraine; lofexidine for opioid withdrawal; 3-D printing 510(k) clearance; Gottleib statement on branded drug companies blocking generics

May 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:03 F...

10:24May 18, 2018

143 - Diacerein 1% for Epidermolysis Bullosa; epoetin alfa biosimilar; MRI with reduced scan time; Gilenya® for pediatric relapsing MS

May 16, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:25 C...

07:30May 16, 2018