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The FDA has approved Comirnaty (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals aged 16 years and older. Comirnaty is the first COVID-19 vaccine to be granted approval by the FDA.
Learn more about Comirnaty
The FDA has approved Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Learn more about Exkivity
The FDA has approved long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), 6-month, the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.
Learn more about Invega Hafyera
The FDA has approved Korsuva (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Korsuva injection is a first-in-class kappa opioid receptor agonist that targets the body’s peripheral nervous system.
Learn more about Korsuva
The FDA has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients aged one year and older with late-onset Pompe disease. Nexviazyme is an enzyme replacement therapy designed specifically to target the mannose-6-phosphate receptor.
Learn more about Nexviazyme
The FDA has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of pediatric patients aged one year and older who weigh at least 11.5kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone.
Learn more about Skytrofa
The FDA has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals aged 1 year and older.
Learn more about Ticovac
The FDA has approved Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Learn more about Welireg
The FDA has approved the first generic version of Chantix (varenicline). The generic varenicline tablet will come in doses of 0.5mg and 1mg.
Learn more about varenicline
The FDA has approved a label update for Keytruda (pembrolizumab) for its indication in first-line advanced urothelial carcinoma. The FDA has converted this indication from an accelerated to a full (regular) approval. In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.
Learn more about Keytruda
The FDA has approved Jardiance (empagliflozin) 10mg to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
Learn more about Jardiance
The FDA has approved a new indication for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Learn more about Jemperli
The FDA has approved the combination of the anti-PD-1 therapy Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma.
Learn more about Keytruda plus Lenvima
The FDA has approved Opdivo (nivolumab) 240mg every two weeks or 480mg every four weeks (injection for intravenous use) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
Learn more about Opdivo
The FDA has approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.
Learn more about Tibsovo
The FDA has approved an expanded peripheral artery disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD.
Learn more about Xarelto plus aspirin
The FDA has approved Xywav (calcium/magnesium/potassium/sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.
Learn more about Xywav
Azurity is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride) for oral solution, 50mg/mL kit to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.
Learn more about the Firvanq recall
ICU Medical, Inc. is voluntarily recalling one lot (2112 units) of Aminosyn II, 15%, an amino acid injection, sulfite-free, intravenous solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material, along with other particles.
Learn more about the Aminosyn II recall
Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi (amifampridine) 10mg tablets, to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria, based on laboratory test results.
Learn more about the Ruzurgi recall
Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique, 30-day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain sibutramine.
Learn more about the 365 Skinny recall
eBay seller jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to the consumer level. FDA analysis has found the product to contain undeclared sibutramine.
Learn more about the Hydro Pineapple Burn recall
KVK Tech, Inc. is voluntarily recalling two lots of atovaquone oral suspension, USP 750mg/5mL, to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.
Learn more about the atovaquone recall
Pfizer is voluntarily recalling all lots of Chantix 0.5mg and 1mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.
Learn more about the Chantix recall
SterRx announced the voluntary nationwide recall of three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1000 mL due to waterborne microbial contamination. SterRx has initiated this voluntary recall of sodium bicarbonate injection, to the hospital pharmacy level.
Learn more about the Sodium Bicarbonate recall
Teligent Pharma is voluntarily recalling one lot of lidocaine HCl topical solution 4%, 50mL in a screw cap glass bottle, to the user level. The product is being recalled because testing has found it to be super-potent based on an out-of-specification result obtained at the 18-month stability time point.
Learn more about the Lidocaine HCl recall
The FDA has provided an update to the Drug Safety Communication issued on February 4, 2021. It has completed its review of a large, randomized safety trial and concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). The FDA is requiring new and updated warnings for the JAK inhibitors Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib).
Learn more about the JAK Inhibitors Drug Safety Communication