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FDAApproves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.
are expected to be approved by the U.S. FDA this year. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. and “Oraxol,” which was licensed out to Athenex, Inc.
Valentine — On November 22, 2022, FDAapproved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA. NEW YORK, Nov.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDAapproval, the U.S.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.
The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method.
Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.
Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]
Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.
Food and Drug Administration (FDA) on Friday, December 11, 2020. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. chief executive officer of Gamida Cell.
Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef ( Endpoints ).
Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review ( Endpoints ).
Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ).
Recent correspondence between the Company and the FDA resulted in modifications to the previously disclosed trial design, including designating overall survival (OS) as the primary endpoint of the study. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development.
Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Vibegron could be a potentially important and differentiated new oral treatment, if approved by the FDA, for patients suffering with OAB.”.
.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDAapproval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Life is on. Gifford, R.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDAapproval, the U.S.
approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020. Before using.
Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S.
Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. The FDAapproved it under the brand name Gavreto on September 4. Here’s a look at the upcoming week. Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer. Revance Therapeutics’ DAXI to Treat Frown Lines.
1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1] 1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1]
Second FDAapproved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,
Food and Drug Administration (FDA). Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The FDAapproved the drug on November 24. Here’s a look.
2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]
FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] J Med Chem. 2020 Feb 27;63(4):1612-1623.
The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy. Photo by Janssen Cilag.
FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The target action date for the FDA decision is September 30, 2022.
Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1
Food and Drug Administration (FDA) approval for the prevention of VTE in all cancer types based on these two Phase 3 studies. ZUG, Switzerland , Jan. The majority of deaths (around 90%) associated with cancer are due to the metastasis of the original tumor cells to sites distant from the initial or primary tumor 1.
Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. . The authorization is temporary and does not replace the formal review and approval process.
1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] Food and Drug Administration (FDA) (Press release). 14 August 2024.
2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).
NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. VICTORIA, British Columbia & ROCKVILLE, Md.–(
FDA Actions. FDAApproval: Last week the FDAapproved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). News information is not all-inclusive and updates are published once a week on Tuesdays. . . Other Industry News.
Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In the U.S.,
FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic.
If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. In September 2020, the U.S.
Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. today announced that the U.S. indications.
The FDA has also granted precedence review to the company’s sBLA for Kymriah in adult cases with r/ r FL. Entering orphan medicine designation from the EC as well as precedence review from the FDA underscores the unmet need and urgency for these cases.
Deuruxolitinib C 17 H 18 N 6 , 314.422 Fdaapproved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,
S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Retrieved 21 December 2023. ^ “Wainua (eplontersen) granted regulatory approval in the U.S. twitter +919321316780 call whatsaapp EMAIL. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634.
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