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The FDA has approved Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab) for all five indications. Cimerli belongs to the anti-VEGF therapy class of biologics.
Learn more about Cimerli
The FDA has approved Kyzatrex (testosterone undecanoate), an oral testosterone replacement therapy indicated in adult males for conditions associated with hypogonadism. Kyzatrex has been approved in three dosage strengths, 100mg, 150mg, and 200mg.
Learn more about Kyzatrex
The FDA has granted tentative approval to Lumryz (sodium oxybate) extended-release oral suspension, a once-at-bedtime investigational formulation for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.
Learn more about Lumryz
The FDA has granted regular approval to Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test. Tabrecta was previously granted accelerated approval for the same indication.
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The FDA has approved Zonisade (zonisamide) oral suspension for adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients aged 16 years and older.
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The FDA has approved Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years or older. Zoryve is the first and only topical phosphodiesterase-4 inhibitor approved for the treatment of plaque psoriasis.
Learn more about Zoryve
The FDA has approved the new tablet formulation of Calquence (acalabrutinib) for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and for patients with relapsed or refractory mantle cell lymphoma, which is approved under accelerated approval based on overall response rate.
Learn more about Calquence
The FDA has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy. The approval extends the current indication in the US to include both lupus and active LN for the intravenous formulation in the pediatric patient population.
Learn more about Benlysta
The FDA has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. Additionally, Enhertu has been approved for the treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
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The FDA has approved Myfembree (estradiol/norethindrone acetate/relugolix) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in premenopausal women, with a treatment duration of up to 24 months.
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The FDA has approved Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.
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The FDA has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients aged 12 years and older. Opzelura is the first and only FDA-approved treatment for re-pigmentation in patients with vitiligo and the only topical formulation of a Janus kinase inhibitor approved in the US.
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The FDA has approved Stelara (ustekinumab) for the treatment of pediatric patients aged 6 years and older with active psoriatic arthritis. This is the fourth indication for Stelara.
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The FDA has approved Xalkori (crizotinib) capsules for the treatment of adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor that is ALK-positive.
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The FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged 5 to less than 12 years who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine approved for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged 5 to less than 12 years following contact with someone with influenza.
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Distributor RFR. is voluntarily recalling lot #48656, Exp. 01/2025 of Sangter Energy Supplement, 3000mg, packaged in 7-count blister packs within a carton, to the consumer level. FDA analysis has found the product to contain undeclared sildenafil.
Learn more about the Distributor RFR Sangter Energy Supplement recall
Edgewell Personal Care Company issued a voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30, to the consumer level. An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can.
Learn more about the Edgewell Personal Care Company Banana Boat Sunscreen recall
Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the FDA that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022, due to product being stored outside of labeled temperature requirements.
Learn more about the Family Dollar OTC medical products recall
Loud Muscle Science is voluntarily recalling multiple Launch Sequence products and lots to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science found the products to be tainted with tadalafil.
Learn more about the Loud Muscle Science Launch Sequence products recall
MKS Enterprise is recalling Dose Vital Honey product sold through its website from March 2022 to July 2022. The product was found to contain the undeclared active pharmaceutical ingredient tadalafil.
Learn more about the MKS Enterprise Dose Vital Honey recall
Plastikon Healthcare is issuing an update to the voluntary recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone 120mg per 30mL oral suspension. This lot was previously subject to a retail level recall and has been added to the current consumer level recall based on updated microorganism speciation data from third-party testing.
Learn more about the Plastikon Healthcare Major products recall
Shopaax.com is voluntarily recalling all lots of Kingdom Honey Royal Honey VIP because it contains undeclared sildenafil.
Learn more about the Shopaax.com Kingdom Honey Royal Honey recall
Ultra Supplement is voluntarily recalling lot number DAP272109, exp 4/1/26 of Sustango capsules packaged in 10-count blisters packaged in a carton, to the consumer level. Amazon notified Ultra Supplement that laboratory analysis found the product to be tainted with tadalafil.
Learn more about the Ultra Supplement Sustango recall
Vi-Jon is revising a previously reported list of all flavors of magnesium citrate saline laxative oral solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the US, Canada, and Panama. This includes all lots of cherry flavor and grape flavor of magnesium citrate saline laxative oral solution, 10 fl. oz. (296mL) within expiry. On July 14, 2022, Vi-Jon recalled all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 fl. oz. (296mL) within expiry. The recall was initiated after Vi-Jon’s third-party microbial testing identified the presence of Gluconacetobacter liquefaciens.
Learn more about the Vi-Jon Magnesium Citrate Saline Laxative recall