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The FDA has approved the supplemental Biologics License Application Bavencio (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Bavencio is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Learn more about Bavencio
The FDA has approved Byfavo (remimazolam) injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Byfavo is a very rapid onset/offset IV benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
Learn more about Byfavo
The FDA approved Crysvita (burosumab-twza) injection to treat patients aged two years and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 that lowers phosphate levels.
Learn more about Crysvita
The FDA has approved Dojolvi (triheptanoin) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders.
Learn more about Dojolvi
The FDA approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients aged 2 years and older. Fintepla will be launched through a restricted distribution program called the Fintepla Risk Evaluation and Mitigation Strategy Program.
Learn more about Fintepla
The FDA has approved Inqovi (decitabine and cedazuridine) tablets, oral hypomethylating agent therapy for intermediate and high-risk myelodysplastic syndromes, including chronic myelomonocytic leukemia. Inqovi is the first approved orally administered hypomethylating agent. It is a fixed-dose combination of the hypomethylating agent decitabine and the cytidine deaminase inhibitor cedazuridine, which prevents degradation of decitabine in the gastrointestinal tract and liver and enables its absorption via oral dosing.
Learn more about Inqovi
The FDA has approved rapid-acting Lyumjev (insulin lispro-aabc) injection 100 and 200 units/mL for the treatment of adults with type 1 and type 2 diabetes. Lyumjev was formulated to speed absorption of insulin into the bloodstream and reduce A1C levels.
Learn more about Lyumjev
The FDA has approved Mycapssa (octreotide) oral delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections. Mycapssa is the first oral somatostatin analogue therapy approved by the FDA.
Learn more about Mycapssa
The FDA has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Learn more about Nyvepria
The FDA approved a new fixed-dose combination of Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for subcutaneous injection to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.
Learn more about Phesgo
The FDA has now approved Rukobia (fostemsavir), 600mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.
Learn more about Rukobia
The FDA has approved Tralement, a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Learn more about Tralement
The FDA approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). Uplizna is only the second approved treatment for the disorder.
Learn more about Uplizna
The FDA has approved the ophthalmic solution Upneeq (oxymetazoline HCl), 0.1%, formerly known as RVL-1201, a novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the only FDA-approved medical treatment for ptosis at this time.
Learn more about Upneeq
The FDA granted accelerated approval to Zepzelca (lurbinectedin) for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent.
Learn more about Zepzelca
The FDA has approved Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis. Cosentyx is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Learn more about Cosentyx
The FDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, single-tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single-tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin for patients with decompensated cirrhosis (Child-Pugh B or C).
Learn more about Epclusa
The FDA approved Ilaris (canakinumab) injection for the treatment of adult-onset Still’s disease. Ilaris was previously approved for systemic juvenile idiopathic arthritis in patients aged 2 years and older.
Learn more about Ilaris
The FDA granted accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (≥10 mutations/megabase) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Keytruda was also recently approved for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation and for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The FDA also approved the FoundationOne CDx assay as a companion diagnostic for Keytruda.
Learn more about Keytruda
The FDA extended the indication of Mylotarg (gemtuzumab ozogamicin) for newly-diagnosed CD33-positive acute myeloid leukemia to include pediatric patients aged 1 month and older.
Learn more about Mylotarg
The FDA approved Opdivo (nivolumab) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Learn more about Opdivo
The FDA granted accelerated approval to Tazverik (tazemetostat), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options. The FDA also approved the cobas EZH2 Mutation Test as a companion diagnostic for Tazverik.
Learn more about Tazverik
The FDA recently approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for oral suspension for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive or treatment-experienced, integrase strand transfer inhibitor-naive pediatric patients aged at least 4 weeks old and weighing at least 3kg.
Learn more about Tivicay and Tivicay PD
The FDA has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA.
Learn more about Tremfya
The FDA granted accelerated approval to Xpovio (selinexor) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Learn more about Xpovio
4e Brands North America is voluntarily recalling ten bottle sizes of hand sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Learn more about the 4e Brands North America hand sanitizer recall
AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Learn more about the AAA Cosmética, S.A. de C.V. bio aaa Advance Hand Sanitizer recall
GSK is voluntarily
recalling to the retail level two lots (02177,
02178) of Children's
Robitussin Honey Cough and Chest Congestion DM and one lot of Children's
Dimetapp Cold and Cough (CL8292), due to the inclusion of incorrect
dosing cups. The dosing cups for the Children's Robitussin Honey product are
missing the 5mL and 10mL graduations, while the dosing cups for the Children's
Dimetapp product are missing the 10mL graduation. The dosing cups packaged with
both products only have the 20mL graduation.
Learn more about the GSK Children's Robitussin Honey Cough and Chest Congestion DM and Children's Dimetapp Cold and Cough recall
Itech 361 is voluntarily recalling 18,940 bottles of All Clean hand sanitizer, moisturizer, and disinfectant sold in one-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Learn more about the Itech 361 All Clean hand sanitizer and moisturizer, and disinfectant recall
Lupin Pharmaceuticals is voluntarily recalling all batches of metformin HCl extended-release tablets USP, 500mg and 1000mg, to the consumer level. FDA analysis revealed that this lot exceeded the acceptable daily intake for N-Nitrosodimethylamine.
Learn more about the Lupin Pharmaceuticals metformin HCl extended-release tablets recall
Mylan Institutional is conducting a voluntary nationwide recall to the consumer level of one lot of daptomycin for injection, 500mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility.
Learn more about the Mylan daptomycin for injection recall
Saniderm is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Learn more about the Saniderm Advanced Hand Sanitizer recall
Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9oz bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Learn more about the Soluciones Cosméticas Bersih Hand Sanitizer Gel Fragrance Free recall
To comply with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mitigate, treat or prevent disease. The recalled drug products are misbranded and deemed unapproved drugs based on labeling claims, which could result in a delay of appropriate treatment by a healthcare provider.
Learn more about the Sundial herbal products recall
Transliquid Technologies is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V., and packaged in an 8.45oz (250mL) bottles, to the consumer level. The firm’s independent testing found the products contain undeclared methanol.
Learn more about the Transliquid Technologies Mystic Shield Protection Topical Solution recall
UVT is voluntarily recalling 38,830 liters of Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). The affected Saniderm Advanced Hand Sanitizer includes lot number 0530, Expiration date 04/2022.
Learn more about the UVT Saniderm Advanced Hand Sanitizer recall
The FDA revoked its decision allowing use of chloroquine phosphate and hydroxychloroquine sulfate to treat people hospitalized with COVID-19 under an emergency use authorization (EUA). Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
Learn more about chloroquine and hydroxychloroquine EUA being revoked
The FDA is warning consumers and healthcare providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.
Learn more about hand sanitizers with methanol
The FDA is warning healthcare providers that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir.
Learn more about remdesivir potential drug interaction
The FDA has issued warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc., 8046255 Canada, Inc. (dba Viatrexx), and World Health Advanced Technologies, Ltd for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law.
Learn more about unapproved injectable drugs labeled as homeopathic