Another Oral Testosterone Undecanoate OK’d for Hypogonadism
The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism. “The FDA approval […]
FDA Approves First Targeted Radioligand Therapy for Metastatic Prostate Cancer
On Wednesday, the FDA approved the first targeted therapeutic radioligand for progressive, metastatic castration-resistant prostate cancer (mCRPC) with prostate-specific membrane antigen (PSMA) expression. Consisting of a targeting compound and a therapeutic radioisotope, lutetium Lu 177 vipivotide tetraxetan (Pluvicto) hones in on PSMA-expressing mCRPC, as identified by a companion diagnostic test (gallium Ga 68 Gozetotide injection, […]
Aducanumab Data Finally Published, but Alzheimer’s Experts Spot Problems
The long-awaited results of the twin phase III trials for aducanumab (Aduhelm), the controversial drug approved last year for early Alzheimer’s disease, were published in the Journal of Prevention of Alzheimer’s Disease (JPAD), a journal whose editor-in-chief is aducanumab researcher and study co-author Paul Aisen, MD, of the University of Southern California in Los Angeles. […]
FDA Approves First Long-Acting Injectable to Prevent HIV Infection
The first long-acting injectable for HIV prevention has now been approved for use, the FDA announced on Monday. Long-acting injectable cabotegravir (CAB-LA, branded as Apretude) is administered as a monthly injection for the first 2 months, then every 2 months afterwards. It is the first long-acting injectable for pre-exposure prophylaxis (PrEP). The drug is approved […]
FDA OKs PD-1 Inhibitor for Adjuvant Treatment of Kidney Cancer
The FDA approved pembrolizumab (Keytruda) for the adjuvant treatment of renal cell carcinoma (RCC) for patients who have an intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, the agency announced. Approval was based on results from the KEYNOTE-564 trial, which demonstrated that adjuvant pembrolizumab following nephrectomy significantly […]
Is There a Vaccine for Malaria? Eligibility, Efficacy, Safety
The World Health Organization approved the first vaccine against malaria, called RTS,S/AS01 (RTS,S), in 2021 for use in children in sub-Saharan Africa. On October 6, 2021, the World Health Organization approved the first vaccine against malaria called RTS,S/AS01 (RTS,S) for use in children in sub-Saharan Africa. RTS,S/AS01 (RTS,S) is not only the first vaccine approved […]
PD-1 Inhibitor OK’d as Adjuvant Therapy for Bladder Cancer
The FDA has approved nivolumab (Opdivo) as an adjuvant therapy for patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status, Bristol Myers Squibb announced. Nivolumab becomes the first PD-1 inhibitor in UC with an indication in the adjuvant […]
FDA Approves First Drug for Von Hippel-Lindau-Associated Tumors
The FDA has approved the first therapy for cancers associated with von Hippel-Lindau (VHL) disease. Belzutifan (Welireg), distributed by Merck, targets hypoxia-inducible factor 2α, which drives growth of malignant and benign tumors in VHL. In the absence of approved systemic therapies, most patients with VHL undergo multiple surgeries in their lifetime to remove renal cell […]
New Enzyme Therapy OK’d for Pompe Disease
The FDA approved avalglucosidase alfa-ngpt (Nexviazyme) on Friday as a new enzyme replacement therapy for Pompe disease. Avalglucosidase alfa is an intravenous drug that targets the M6P receptor, and is indicated for late-onset disease for those ages 1 year and older. In patients with the disease, which is marked by dysfunction of the lysosomal enzyme […]
Third Dose a Charm in Israel? Door-to-Door ‘Goons’; Cervids Catch COVID, Too!
Note that some links may require registration or subscription. Israel approved a third shot of Pfizer’s COVID-19 vaccine for citizens over 60 years of age. (Times of Israel) Shortly after President Biden urged the Defense Department to make COVID-19 vaccines mandatory for military personnel, the Pentagon said it would start talks on exactly that. (The […]