The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents
27 November 2017
FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents

On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention. Read more

FDA Advisory Committee Votes Negatively on Safety and Effectiveness of Bayer’s Ciprofloxacin Inhalation Powder
27 November 2017
FDA Advisory Committee Votes Negatively on Safety and Effectiveness of Bayer’s Ciprofloxacin Inhalation Powder

The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) convened on November 16th to discuss ciprofloxacin inhalation powder (NDA 209367). Read more

FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial
26 November 2017
FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial

On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical. Read more

FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder
25 November 2017
FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee. Read more

FDA Advisory Committee Recommends Approval of Novo Nordisk’s Type 2 Diabetes Drug, Semaglutide
24 November 2017
FDA Advisory Committee Recommends Approval of Novo Nordisk’s Type 2 Diabetes Drug, Semaglutide

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th. Read more

FDA Advisory Committee Votes in Favor of Rhopressa™
23 November 2017
FDA Advisory Committee Votes in Favor of Rhopressa™

On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254). Read more

FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine
22 November 2017
FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine

The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster. Read more

FDA Advisory Committee Unanimously Recommends Approval of LUXTURNA for Patients with Biallelic RPE65-mediated Inherited Retinal Disease
21 November 2017
FDA Advisory Committee Unanimously Recommends Approval of LUXTURNA for Patients with Biallelic RPE65-mediated Inherited Retinal Disease

On October 12th, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met to discuss and make recommendations. Read more

FDA Panel Votes Data Are Inconclusive For Approval of Ataluren® For Treatment Of Patients With Dystrophinopathy
20 November 2017
FDA Panel Votes Data Are Inconclusive For Approval of Ataluren® For Treatment Of Patients With Dystrophinopathy

The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee met on September 28th to discuss the new drug application (NDA 200896) for Ataluren®. Read more

Split Decision from FDA Advisory Committee on Approval for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery
16 November 2017
Split Decision from FDA Advisory Committee on Approval for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery

On September 19th the Oncologic Advisory Committee (ODAC) discussed supplemental new drug application (sNDA 021938/033) for SUTENT® (sunitinib malate) oral capsules, submitted by C.P. Read more

FDA Advisory Committee Discusses Pediatric Study Data for Opioid Analgesic
15 November 2017
FDA Advisory Committee Discusses Pediatric Study Data for Opioid Analgesic

The FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) convened on September 14th. Read more

FDA Advisory Committee Does Not Support Approval of Opioid with Blue Dye Deterrent
07 November 2017
FDA Advisory Committee Does Not Support Approval of Opioid with Blue Dye Deterrent

On July 26th, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee. Read more

Mylan Achieves Unanimous Support for MYL-1401O: A Proposed Biosimilar to Genentech’s Herceptin (trastuzumab)
06 November 2017
Mylan Achieves Unanimous Support for MYL-1401O: A Proposed Biosimilar to Genentech’s Herceptin (trastuzumab)

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the afternoon of July 13th to discuss Biologics License Application (BLA) 761074 for Mylan’s biosimilar to Genentech Inc.’s Herceptin (trastuzumab). Read more

Amgen Gains Unanimous Approval for ABP 215: A Proposed Biosimilar to Genentech/Roche’s AVASTIN (bevacizumab)
02 November 2017
Amgen Gains Unanimous Approval for ABP 215: A Proposed Biosimilar to Genentech/Roche’s AVASTIN (bevacizumab)

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the morning of July 13th to discuss Biologics License Application (BLA) 761028. Read more

FDA Approves Kymriah, the First Ever Therapy Based on Gene Transfer
01 November 2017
FDA Approves Kymriah, the First Ever Therapy Based on Gene Transfer

On July 12th, 2017 the FDA’s Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 125646 for tisagenlecleucel-T suspension (KYMRIAH™). Read more

FDA Advisory Committee Supports Approval of XELJANZ/XELJANZ XR for the Treatment of Psoriatic Arthritis
30 October 2017
FDA Advisory Committee Supports Approval of XELJANZ/XELJANZ XR for the Treatment of Psoriatic Arthritis

On August 3rd, the FDA’s Arthritis Advisory Committee (AAC) recommended the approval of Pfizer’s tofacitinib tablets for a new indication. Read more

WYETH GAINS FDA COMMITTEE SUPPORT FOR INTRAVENOUS GEMTUZUMAB: A TREATMENT FOR ADULTS WITH DE NOVO ACUTE MYELOID LEUKEMIA
17 October 2017
WYETH GAINS FDA COMMITTEE SUPPORT FOR INTRAVENOUS GEMTUZUMAB: A TREATMENT FOR ADULTS WITH DE NOVO ACUTE MYELOID LEUKEMIA

On July 11th the Oncologic Drugs Advisory Committee (ODAC) held a half-day meeting to discuss the biologics license application (BLA) 761060. Read more

FDA Committee Discusses Potential Pediatric Applications for Adult Cancer Products Currently Under Development
17 October 2017
FDA Committee Discusses Potential Pediatric Applications for Adult Cancer Products Currently Under Development

On June 21st & 22nd, the Oncologic Drugs Advisory Committee (ODAC) explored pediatric development plans, to gauge investigator interest, for multiple products currently under development for adult cancer indications. Read more