February 23rd 2024
The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.
February 22nd 2024
While no company has yet achieved the full promise of AI to radically accelerate time to market, meaningful strides are being made across the drug discovery funnel.
February 21st 2024
The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.
Merck seeks approval for Keytruda (pembrolizumab) plus chemotherapy with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel).
Tecvayli is an off-the-shelf bispecific antibody previously granted accelerated approval by the FDA for adults with relapsed/refractory multiple myeloma.
WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy
Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.
Servier’s Potential First-in-Class Targeted Therapy for IDH-Mutant Gliomas Granted FDA Priority Review
The FDA has assigned a Prescription Drug User Fee Act action date of August 20, 2024, for Servier’s New Drug Application for vorasidenib.
FDA Gives Priority Review Status to Bristol Myers Squibb’s sNDA for Krazati Combo in Colorectal Cancer
The FDA assigned the supplemental new drug application for Krazati (adagrasib) plus cetuximab in patients with locally advanced or metastatic colorectal cancer with a Prescription Drug User Fee Act goal date of June 21, 2024.
AstraZeneca’s Tagrisso With Chemotherapy Gets FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer
The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.
FDA Grants Accelerated Approval to Iovance’s Amtagvi for Unresectable or Metastatic Melanoma
Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer.
Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients
Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.
FDA Grants Traditional Approval to Tepmetko for Metastatic Non–Small Cell Lung Cancer
The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.
Citius Pharmaceuticals Resubmits BLA for Lymphir to Address FDA Complete Response Letter
Lymphir is an immunotherapy under evaluation for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma following at least one previous line of systemic therapy.
FDA Clears Masimo’s MightySat Fingertip Pulse Oximeter
The MightySat Fingertip Pulse Oximeter is reportedly the first pulse oximeter available without a prescription.
Bristol Myers Squibb’s Augtyro Granted FDA Priority Review for NTRK-Positive Locally Advanced, Metastatic Solid Tumors
Augtyro is a potential best-in-class tyrosine kinase inhibitor that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors.
FDA Approves Ipsen’s Onivyde Combination for Metastatic Pancreatic Adenocarcinoma
Pancreatic adenocarcinoma is the most common form of pancreatic cancer, with more than 60,000 diagnoses per year in the United States.
FDA Grants Fast Track Designation to BioXcel Therapeutics' Novel Prostate Cancer Therapy
BXCL701 is an oral innate immune activator being investigated in combination with Keytruda (pembrolizumab) in patients with metastatic small cell neuroendocrine prostate cancer.
FDA Fast Tracks GSK's Bepirovirsen for Chronic Hepatitis B Virus
In clinical trials, bepirovirsen showed the potential to address a significant unmet medical need for patients with chronic hepatitis B by reducing hepatitis B surface antigen levels and HBV DNA.
FDA Approves Takeda’s Eohilia, an Oral Treatment for Eosinophilic Esophagitis
Takeda expects Eohilia single-dose stick packs will be available by the end of February for patients aged 11 years and older with eosinophilic esophagitis.
Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death
Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.
Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.
FDA Fast Tracks Arvinas' and Pfizer’s Vepdegestrant for ER-Positive/HER2-Negative Breast Cancer
Vepdegestrant (ARV-471) is a noval PROTAC ER degrader found to harness the body’s own natural protein disposal system to eliminate disease-causing proteins.
FDA Fast Tracks Antibody-Drug Conjugate for Ovarian, Fallopian Tube, Primary Peritoneal Cancers
BioNTech SE and Duality Biologics' next-generation antibody-drug conjugate is being evaluated for patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
FDA Grants Priority Review to Expand Indication of GSK's Arexvy for RSV Protection in Adults Aged 50-59 Years
The FDA assigned a Prescription Drug User Fee Act action date of June 7, 2024, to an application that would expand the indication of Arexvy to include adults 50-59 years with an increased risk of respiratory syncytial virus-related lower respiratory tract disease.
FDA Fast Tracks Ultimovacs' Novel Cancer Vaccine for Malignant Pleural Mesothelioma
UV1 plus ipilimumab (Yervoy) and nivolumab (Opdivo) produced a statistically significant and clinically meaningful survival improvement in patients with unresectable malignant pleural mesothelioma.
Novartis Terminates Licensing Rights With Allarity for Cancer Drug Due to Missed Payments
Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.
FDA Grants Priority Review to Adaptimmune's T-Cell Therapy for Advanced Synovial Sarcoma
The biologics license application for afamitresgene autoleucel, an engineered T-cell receptor drug, was assigned a PDUFA date of August 4, 2024.
Johnson & Johnson Seeks Approval for Darzalex Faspro Combo in Newly Diagnosed Multiple Myeloma
Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma.
Bristol Myers Squibb's Breyanzi Granted FDA Priority Review for R/R Follicular Lymphoma, Mantle Cell Lymphoma
CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to be evaluated in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo's Enhertu for HER2+ Solid Tumors
Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.
Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products
Atypical antidepressant linked to severe adverse effects and death as a result of misuse.
FDA Approves Expanded Indication for Dupixent to Treat Eosinophilic Esophagitis in Pediatric Patients
The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.
FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies
FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.
FDA Approves Expanded Indication for Heron Therapeutics, Inc’s Zynrelef
The expanded indication for Zynrelef now includes soft tissue and orthopedic surgical procedures.
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