July 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Ass

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

Jul 23rd, 2018 9m 24s

July 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who hav

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

Jul 19th, 2018 14m 43s

July 19, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Base

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

Jul 16th, 2018 8m 32s

July 16, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:38 FDA approves the first drug with an indication for treatment of smallpox https://www.prnewswire.com/ne

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

Jul 12th, 2018 14m 45s

July 12, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.co 0:35 Recursion Receives FDA Clearance of Investigational New Drug Application to Initiate First Clinical Tr

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

Jul 9th, 2018 9m 45s

July 9, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49 Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To S

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

Jul 2nd, 2018 11m 58s

July 2, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:44 Array BioPharma Announces FDA Approval of BRAFTOVI™ (encorafenib) in Combination with MEKTOVI® (binimet

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

Jun 28th, 2018 9m 47s

June 28, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0.33 FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe f

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.

Jun 25th, 2018 8m 53s

June 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:44 FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis

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

Jun 21st, 2018 11m 3s

June 21, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:47 FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Diff

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

Jun 18th, 2018 10m 58s

June 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatmen

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

Jun 14th, 2018 15m 58s

June 14, 2018Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:48 Samus Therapeutics Announces PU-H71 Granted Orphan Drug Designation and First Patient Dosed in Phase 1b S

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

Jun 11th, 2018 9m 29s

June 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:58 AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a

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

Jun 7th, 2018 12m 15s

June 7, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:50 FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment h

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:

Jun 1st, 2018 19m 20s

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/NewsEvents/Newsroom/PressAnnouncements/ucm609258.htm 2:38 FDA approves new treatment for moderately to severely

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 30th, 2018 13m 48s

May 30, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:01 Pfizer’s XALKORI® (crizotinib) receives FDA breakthrough therapy designation in two new indications http

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

May 25th, 2018 10m 14s

May 25, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:49 FDA approves a new treatment for PKU, a rare and serious genetic disease https://www.fda.gov/NewsEvents/

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.

May 23rd, 2018 16m 30s

Wednesday, May 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 FDA to review Zynquista™ (sotagliflozin) as potential treatment for type 1 diabetes https://w

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

May 18th, 2018 10m 24s

May 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:03 FDA approves novel preventive treatment for migraine https://www.prnewswire.com/news-releases/fda-appro

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

May 16th, 2018 7m 30s

May 16, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:25 Castle Creek Pharmaceuticals Receives FDA Rare Pediatric Disease Designation for Diacerein 1% Ointment

142 - Debio 1347 for FGFR gene alteration tumors; daratumumab for newly diagnosed MM; new combo for OAB; FDA warns e-liquid companies; 'Short-term' EpiPen shortage

May 11th, 2018 10m 42s

May 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:46 FDA grants Fast Track Designation to Debiopharm International's Debio 1347 for the treatment of patients

141 – Hemospray for GI bleeding; atezolizumab priority review in initial NSCLC; FDA requiring restaurants to post calorie counts

May 8th, 2018 8m 19s

May 8, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:25 FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding https://www.fda.go

140 - HSC660 for female hair loss; Clearance of cardiac advanced mapping catheter; 5F9 for DLBCL and FL

May 4th, 2018 9m 26s

May 4, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com US FDA Approves Histogen IND for Female Hair Loss Trial https://www.prnewswire.com/news-releases/us-fda-appro

139 - Vortioxetine improvement in processing speed in MDD; ULTRA contact lenses for extended wear; first of kind spine disposable instrument kit; Fast Track for RGX-121 in MPS II

May 3rd, 2018 11m 41s

May 3, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:29 TRINTELLIX® (vortioxetine) prescribing information now includes new data showing improvement in processi

137 - Tafinlar + Mekinist for BRAF V600-mutant melanoma; elamipretide for treatment of Leber's hereditary optic neuropathy; macitentan for CTEPH

May 1st, 2018 10m 21s

May 1, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:22 Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melano