New FDA Approvals Podcast Episodes Online

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New FDA Approvals Podcast Episodes Online | Radio and Podcast

Episodes

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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

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 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:46 F...

10:42May 11, 2018

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

May 8, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:25 FD...

08:19May 8, 2018

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

May 4, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com US FDA...

09:26May 4, 2018

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 3, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:29 TR...

11:41May 3, 2018

138 - Kymriah for large B-cell lymphoma; women underrepresented in some clinical trials; FDA takes action against kid friendly e-cigarette products.

May 2, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:47 Ky...

11:23May 2, 2018

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

May 1, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:22 No...

10:21May 1, 2018

136 - Pembrolizumab + pemetrexed for NSCLC; FDA clearance for the LungVision tool; cemiplimab for advanced cutaneous squamous cell carcinoma

Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com April 30, 2018 1:16...

08:18Apr 30, 2018

135 - Rubraca assay for ovarian cancer; tolvaptan in inherited kidney disorder; halting of trastuzumab biosimilar approval; FDA promotes artificial intelligence in health care

April 27, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:11...

09:40Apr 27, 2018

134 - Pimavanserin safety in Parkinsons; Trelegy in COPD; FDA approves implant for detecting heart attacks; Lumendi's endoscopic surgery accessory

April 26, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:20...

11:09Apr 26, 2018

133 – Baricitinib for moderately-to-severely active rheumatoid arthritis; LBS-007 for ALL; FDA statements on youth use of, and access to, JUUL and other e-cigarettes and Fiscal Year 2019 budget

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

10:19Apr 25, 2018

132 – MALDI-TOF test for C. auris; FDA issues guidances for opioid use disorder; 510(k) clearance for beacon transponder used in lung SBRT

April 24, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:10...

10:05Apr 24, 2018

131 - New formulation of Akynzeo for CINV; FDA approves preterm birth risk test; FDA approves IDE trial for Urotronic's drug-coated balloon

April 23, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:10...

07:22Apr 23, 2018

130 - Osimertinib for first-line NSCLC plus EGFR Mutation Test v2 test; OVOMotion™ shoulder arthroplasty system; Fiscal Year 2019 budget request comments

April 20, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:20...

09:33Apr 20, 2018

129 - Fostamatinib for CITP; KL1333 for mitochondrial diseases; Praxbind reversal agent for Pradaxa; therapy for inherited rickets; FDA statements on arsenic in rice and medical device safety and innovation

April 19, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:58...

10:43Apr 19, 2018

128 - Nivolumab/ipilimumab for frontline RCC; CRISPR for beta thalassemia in Europe; VAR 200 for FSGS

April 18, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:08...

10:39Apr 18, 2018

127 – Trabecular Metal™ cementless tibia; FDA warns about romaine lettuce e.coli; model-informed drug development

April 17, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:05...

08:16Apr 17, 2018

126 - NDA for ALKS5461; clearance for cobas® CT/NG for cobas® 6800/8800 Systems; FDA cracks down on dietary supplements with caffeine

April 16, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:26...

09:26Apr 16, 2018

125 - Guidance for next generation sequencing-based tests; OCS™ lung system approval; Clinical hold lifted on BPX-501; machine learning and brain cells �

April 13, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:28...

11:14Apr 13, 2018

124 - IDx-DR approval for diabetes eye problems; everolimus for tuberous sclerosis complex (TSC) seizures.

Thursday, April 12, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapproval...

11:13Apr 12, 2018

123 - Contact lens with light-adaptive technology; Amazon and the FDA; Elagolix in Endometriosis-Associated Pain

April 11, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:12...

09:40Apr 11, 2018

122 - FDA restrictions on Essure; exparel for pain relief after shoulder surgery; Varian launches velocity 4.0 cancer imaging software

April 10, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:11...

08:22Apr 10, 2018

121 - rucaparib for ovarian cancer; antimicrobial post-therapy gel; digital health clearances in 2018; FDA releases plan for Biosimilar User Fee Act

April 9, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:27...

09:06Apr 9, 2018

Slow News Days

The last couple of days (Thursday and Friday, April 5th and 6th, 2018) have been very slow with regard to new approvals and other FDA-relate...

Apr 6, 2018

Audio unavailable

120 - Bydureon Add-On Therapy in T2D; mandatory recall for kratom; GORE® CARDIOFORM for stroke; comprehensive® augmented baseplate for shoulder reconstruction.

April 4, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:19...

10:37Apr 4, 2018

119 - FDA refuses Alkermes' depression treatment; EU expanded indication for denosumab; FDA approval for Impella CP®; FDA's efforts to enhance the patient perspective.

April 3, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:12...

09:42Apr 3, 2018

118 - Blinatumomab given accelerated approval; FDA grants Orphan Drug Designation to CYP-001 for GVHD; FDA to consider what 'healthy' means.

March 30, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:46...

12:08Mar 30, 2018

117 - Symfi™ once-daily HIV combo; FDA working on a 'dozen' policies to boost copycat biotech drugs; FDA panel backs approval of lofexidine for opioid withdrawal.

March 29, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1.02...

08:36Mar 29, 2018

116 – first fully interoperable continuous glucose monitoring system; Anti-smoking groups sue FDA; Final approval of ANDA entecavir tablets; FDA approves Toujeo® Max SoloStar®; FDA Approves New Innovations on Hologic's 3Dimensions™ Mammography Syste

Wednesday March 28, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapproval...

10:25Mar 28, 2018

115 - Safety outcomes update on Tresiba® label; myBioness™ iOS app; X Smart Glucose Meter; ORTHO CONNECT software clearance.

March 27, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:05...

08:30Mar 27, 2018

114 - FDA has a drugs@FDA app; FDA moves to limit ingredients for bulk drug compounding; PhysioWave's pulse wave velocity feature gets FDA clearance

Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 1:05 FDA has a new...

07:58Mar 26, 2018