Drugs
FDA has approved an Ocular Therapeutix supplemental NDA to broaden Dextenza’s (dexamethasone ophthalmic insert) label to add an additional indication for treating ocular itching associated with allergic conjunctivitis. Previously the corticosteroid was approved for treating ocular pain and inflammation following ophthalmic surgery. The new approval was based on data
Biologics
FDA has approved Enzyvant Therapeutics’ thymus tissue-based product Rethymic for treating pediatric patients with congenital athymia, a rare immune disorder in which a child is born without a thymus – an organ that helps the body learn to fight infections. “Children impacted by this disease typically die within the first
Drugs
Athenex has decided to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer. After the company received an NDA complete response letter earlier this year, which recommended an additional clinical study before considering the submission for approval, the company requested a Type A meeting with
Biologics
FDA has granted Y-mAbs Therapeutics a rare pediatric disease designation for the company’s lutetium-labeled omburtamab antibody program for treating medulloblastoma. The therapy is currently in a multicenter Phase 1 clinical trial in pediatric patients with refractory medulloblastoma, and in a multicenter Phase 1 clinical trial targeting B7-
Devices
FDA has granted Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimer’s Disease (AD). The designation was granted based on the test’s ability to detect low-abundance markers in a blood sample, which may provide earlier, more accessible
Drugs
Merck has filed an application seeking emergency use authorization (EUA) for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine that new data show significantly reduced the risk of hospitalization or death in Covid-19 patients. Earlier this month, Merck and developmental partner Ridgeback Biotherapeutics announced data from a
FDA Policy/General
Labeling Recommendations for Surgical Staplers 10/8/2021 Federal Register notice: FDA has announced a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The labeling recommendations are intended to address device malfunctions and misuse. To view the notice, click here. Surgical Staplers Up-classified to Class
FDA Policy/General
DRUGS FDA has approved a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Approval was based on data from two 12-week trials
FDA Policy/General
Sevion Therapeutics and Eloxx Pharmaceuticals, a clinical stage company developing therapeutics for genetic diseases caused by non-sense mutations, have agreed to an acquisition transaction. Under the agreement, Eloxx will become a wholly owned subsidiary of Sevion. Bristol-Myers Squibb and Qiagen have entered into an agreement to explore using
Drugs
FDA has approved a ChemoCentryx NDA for Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy. The systemic autoimmune disease is caused by over-activation of the
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 17-0 to recommend approval of Takeda’s maribavir to treat cytomegalovirus (CMV) infection in the post-transplant setting. Panel members agreed with an agency briefing document that while the two trials submitted had significant limitations, there is a considerable unmet need
FDA Policy/General
Federal Register notice: FDA has announced a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The labeling recommendations are intended to address device malfunctions and misuse. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify surgical staplers for internal use from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The agency is issuing the reclassification on its own initiative based on new information. Between 1/2011 and 3/
Drugs
A new FDA pilot program on using novel excipients aims to increase their use, especially if they have potential public health benefits. The pilot was initiated after the agency continually heard that drug developers may fear that introducing novel excipients could cause problems or delays with their drug applications, according
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psoriatic arthritis (jPsA). The biologic targets cytokines interleukin (IL)-12 and IL-23, both of which have a role in inflammation associated with immune-mediated diseases, according to the
Drugs
FDA has granted Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients. According to the company, the designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque in the ongoing SCarlet RoAD and Marguerite RoAD
Devices
FDA has issued a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and facial fillers (dermal fillers or fillers). The agency says serious adverse events have been reported in connection with their use, such as permanent
FDA Policy/General
Federal Register notice: FDA has announced a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting. On 10/14, panel members will discuss an emergency use authorization (EUA) for Moderna’s Covid–19 mRNA vaccine for administering a booster dose in individuals 18 years of age and older.
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. The document describes how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act to human drug products
Devices
FDA says the Imperative Care 8/18 recall of specific lots of its ZOOM 71 reperfusion catheter due to the risk of breaks during use is Class 1. The company recalled 3,098 devices distributed in the U.S. between 9/23/20 and 8/9/21. Imperative Care says
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. Device labeling requirements provide for the label or labeling
Drugs
FDA has granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. An agency announcement says FDA recognized a portion of the database as a source of valid