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The FDA has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
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The FDA has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in epilepsy patients aged 12 years or older.
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The FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy.
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The FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.
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The FDA approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children aged less than 2 years with spinal muscular atrophy (SMA). The product is an adeno-associated virus vector-based gene therapy that targets the cause of SMA.
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The FDA approved Corlanor (ivabradine) oral solution to reduce the risk of hospitalization for worsening heart failure (HF) in adult patients with stable, symptomatic chronic HF with reduced left ventricular ejection fraction and for the treatment of stable symptomatic HF due to dilated cardiomyopathy in pediatric patients aged 6 months and older. Corlanor is also available as a tablet for oral use.
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The FDA approved Cyramza (ramucirumab) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400ng/mL and have been previously treated with sorafenib. This is the fifth FDA approval for Cyramza.
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The FDA has approved Emgality (galcanezumab-gnlm) injection (300mg) for the treatment of episodic cluster headache in adults. Emgality is given by patient self-injection.
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The FDA approved Eylea (aflibercept) injection solution to treat all stages of diabetic retinopathy. Eylea, a vascular endothelial growth factor inhibitor, is already approved in the US for neovascular age-related macular degeneration, macular edema after central retinal vein occlusion, and diabetic macular edema.
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The FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged 1 month and older. VTE can include deep vein thrombosis and pulmonary embolism.
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The FDA has extended the indication for Gattex (teduglutide) injection to children as young as aged 1 year with short bowel syndrome (SBS) who need additional intravenous parenteral support. Gattex is the only glucagon-like peptide-2 analogue approved that improves intestinal absorption in patients with SBS who are dependent on parenteral support. It was approved for adults with SBS in 2012.
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The FDA has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients aged 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication.
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The FDA has approved Lyrica (pregabalin) for pediatric patients aged 1 month and older as adjunctive therapy for the treatment of partial-onset seizures. Lyrica was approved previously for children aged ≥4 years.
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The FDA has approved Sorilux (calcipotriene) foam 0.005% for the treatment of plaque psoriasis of the scalp and body in adolescents aged 12 years or older.
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The FDA has approved an expanded indication for Victoza (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. This glucagon-like peptide-1 receptor was first approved in the US in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
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The FDA has approved Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder in adults. Vraylar is also approved in the US to treat manic or mixed episodes associated with bipolar I disorder in adults.
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The FDA has approved broadening the indication for Xeomin (incobotulinumtoxinA) as first-line therapy for blepharospasm in adult patients. The intramuscular injectable drug was already indicated for patients with benign essential blepharospasm who have been previously treated with Botox (onabotulinumtoxinA).
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The FDA approved Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.
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The FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.
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The FDA approved Revlimid (lenalidomide) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.
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The FDA approved Venclexta (venetoclax) in combination with obinutuzumab for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Drip More is voluntarily recalling four lots (03021819-1, 03021819-2, 03021819-3, 03021819-4) of Candy King — Worms 3mg/100mL that were produced by a contract manufacturer. The product has been found to contain a higher concentration of nicotine than the label indicates.
Learn more about the Drip More Candy King – Worms recall
Heritage Pharmaceuticals is initiating a voluntary recall of amikacin sulfate injection, USP, 1g/4mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and prochlorperazine edisylate injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot of Lot VEAC025, which may indicate a lack of sterility in the other sublots.
Learn more about the Heritage Pharmaceuticals amikacin sulfate and prochlorperazine edisylate injections recalls
Novartis announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5mg for oral suspension, to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. Promacta tablets in 12.5mg, 25mg, 50mg, and 75mg strengths are not impacted by this recall and are not manufactured in the same facility.
Learn more about the Novartis Promacta oral suspension recall
Novis PR is voluntarily recalling 5 lots of Pecgen DMX, 16 oz, a liquid cough syrup, to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours, or as directed by a physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours, or as directed by a physician. Additionally, the label does not advise consumers to consult a physician for children under 2 years of age.
Learn more about the Novis PR Pecgen DMX cough syrup recall
Pharm D Solutions is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by the FDA.
Learn more about the Pharm D Solutions sterile compounded drug products recall
Teva Pharmaceuticals has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the US of losartan potassium tablets. This expanded recall includes six lots of bulk losartan potassium USP tablets (two lots of 50mg strength and four lots of 100mg strength) due to the detection of an impurity above the interim acceptable exposure limit of 9.82 ppm. The source of the N-nitroso-N-methyl 4-aminobutyric acid (NMBA) that is impurity was detected in one lot of active pharmaceutical ingredient manufactured by Hetero Labs Limited, which was used in the manufacturing of the six bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.
Learn more about the Teva Pharmaceuticals losartan potassium tablets recall
The FDA is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women who could become pregnant. According to data reviewed by the FDA, consumption of vinpocetine is associated with adverse reproductive effects, including miscarriage or harm fetal development. Hence, they are advising pregnant women and women who could become pregnant not to take vinpocetine, which may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract.
Learn more about vinpocetine use in women of childbearing age