December 4th 2023
Pirtobrutinib (Jaypirca) is a next-generation, highly selected, non-covalent BTK inhibitor that has shown nanomolar potency against wild-type and C481-mutant BTK in cell and enzyme assays.
December 1st 2023
Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy of gemcitabine plus cisplatin or carboplatin.
FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or metastatic breast cancer.
November 30th 2023
Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi and Sympazan.
KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies.
FDA Accepts sNDA for Roflumilast Following Promising Trial Results in Atopic Dermatitis
Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and a pair of Phase 1 pharmacokinetic studies for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older.
FDA Accepts New Drug Application for Novel Schizophrenia Treatment
Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia.
FDA Grants 510(k) Clearance to Obstructive Sleep Apnea Oral Appliance
The clearance includes the Vivos Therapeutics, Inc's DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance for adults with severe obstructive sleep apnea.
FDA Approves First Treatment for Adults With Progressing Desmoid Tumors
Results from the Phase 3 DeFi trial (NCT03785964) showed that nirogacestat (Ogsiveo) reduced the risk of disease progression or mortality by 71% compared with placebo.
FDA Awards Breakthrough Designation to Epkinly for Follicular Lymphoma
Epcoritamab-bysp (Epkinly; AbbVie and Genmab) is a T-cell engaging bispecific antibody under evaluation for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.
FDA Grants Fast Track Designation to Investigational Food Allergy Immunotherapy
The FDA granted Fast Track Designation to ADP101 based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies.
Truqap Plus Faslodex Approved by FDA for Advanced HR+/HER2– Breast Cancer
First-in-class combination of capivasertib (Truqap) plus fulvestrant (Faslodex) approved for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.
FDA Approves Xtandi for Nonmetastatic Castration-Sensitive Prostate Cancer
Astellas Pharma and Pfizer Inc's enzalutamide (Xtandi) gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Keytruda Combination Gets FDA Approval for Gastric, GEJ Adenocarcinoma
Merck’s pembrolizumab (Keytruda) combined with fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Augtyro Gets FDA Approval for Locally Advanced, Metastatic ROS1-Positive Non-Small Cell Lung Cancer
The FDA's approval of Bristol Myers Squibb’s repotrectinib (Augtyro) was based on findings from the open-label, single-arm, Phase 1/2 trial TRIDENT-1, which evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of the drug in patients with advanced solid tumors.
Defencath Approved by FDA for Catheter-Related Bloodstream Infections in Patients With with Kidney Failure
The Phase 3 LOCK-IT-100 clinical trial for DefenCath was recommended for an early termination based on the demonstrated efficacy in treating catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis.
FDA Approves Diagnostic Tool to Identify Suitable Candidates for Keytruda in Treatment of Gastric, Gastroesophageal Junction Adenocarcinoma
In addition to its latest indication, PD-L1 IHC 22C3 pharmDx can help identify patients with non–small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer who may derive a benefit from treatment with pembrolizumab (Keytruda).
Phase 3 Trial Results Lead to FDA Approval of Expanded Indications for Exparel
FDA expands indication for Pacira BioSciences, Inc's bupivacaine liposome injectable suspension (Exparel) as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Valneva’s Ixchiq Becomes First FDA-Approved Vaccine for Chikungunya Virus
A pivotal Phase 3 trial for Ixchiq showed a 98.9% seroresponse rate at 28 days following a single immunization to prevent disease caused by chikungunya virus.
FDA to Evaluate sBLA for Third Interchangeable Humira Biosimilar
Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) could become the third Humira biosimilar deemed interchangeable, following Cyltezo and Abrilada.
FDA Approves Adzynma for Congenital Thrombotic Thrombocytopenic Purpura
Adzynma was previously granted a FDA Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations for patients with congenital thrombotic thrombocytopenic purpura.
FDA Restricts Keytruda Approval for Certain Patients With Gastric Cancer
The FDA granted accelerated approved in May 2021 to pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Fruzaqla to Treat Adults With Metastatic Colorectal Cancer
Fruzaqla may help to provide a significant survival benefit to patients with metastatic colorectal cancer without negatively impacting quality of life.
FDA Approves Significant New Treatment for Chronic Weight Management
Tirzepatide (Zepbound; Eli Lilly and Company) is as the first and only FDA-approved medication for obesity that activates GIP and GLP-1 hormone receptors.
Kura Oncology, Mirati Therapeutics Enter into Clinical Collaboration and Supply Agreement to Evaluate KO-2806 and Adagrasib in Non-Small Cell Lung Cancer
Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.
FDA Approves Abbott's HPV Test to Run on Alinity M Assay Platform
The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.
Partial Clinical Hold Placed on Phase 1 Trial for Investigational Drug for B-Cell Malignancies
The FDA placed a partial hold on a phase 1 trial for the Bruton tyrosine kinase degrader NX-2127 for the treatment of patients with relapsed/refractory B-cell malignancies.
FDA Approves Vonoprazan for the Treatment of Erosive Esophagitis
Phathom Pharmaceuticals announced that it anticipates vonoprazan (Voquenza) to be commercially available by December 2023.
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma
SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.
CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel for Severe Sickle Cell Disease
Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.
FDA Approves Cosentyx as Treatment Option for Hidradenitis Suppurativa
The branded form of secukinumab is currently the only FDA-approved fully human biologic that directly inhibits interleukin-17A.
FDA Approves Expanded Indication for Abatacept to Treat Juvenile Psoriatic Arthritis
Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.
Arrivent’s Furmonertinib Receives FDA Breakthrough Therapy Designation
Furmonertinib is in development for the treatment of advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.
FDA Approves Interchangeable Ustekinumab Biosimilar for Inflammatory Diseases
The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.
FDA Approves Keytruda Plus Chemotherapy for Biliary Tract Cancer
The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.
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