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The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for tradipitant; Apple’s sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma [...]

The Food and Drug Administration (FDA) has granted accelerated approval to Livdelzi[sup.®] (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UCDA) in adults who [...]

The table below is a review of notable updates that occurred in July 2024 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Allergic Disorders Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) Oral immunotherapy Treatment of pediatric patients aged 1 to 3 years with peanut allergy. (https://www.empr.com/home/news/palforzia-approval-expanded-to-younger-patients-with-peanut-allergy/) Palforzia [...]

The Food and Drug Administration (FDA) has approved Tecelra[sup.® ](afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, [...]

The Food and Drug Administration (FDA) has approved Erzofri[sup.®] (paliperidone palmitate) extended-release injectable suspension for the treatment of schizophrenia in adults and schizoaffective disorder in adults as monotherapy and as [...]

Treatment with CAM2029, an investigational once-monthly octreotide subcutaneous (SC) depot, was found to be safe and effective in patients with acromegaly, according to results from a phase 3, long-term safety [...]

Treatment with vutrisiran was associated with a significant reduction in the composite of all-cause mortality and recurrent cardiovascular (CV) events in patients with transthyretin amyloidosis (ATTR) with cardiomyopathy, according to [...]

The table below is a review of notable updates that occurred in May 2024 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Hematological Disorders Bkemv (eculizumab-aeeb) Complement inhibitor Treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis, and for the treatment of patients with atypical [...]

The table below is a review of notable updates that occurred in April 2024 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Dermatological Disorders Selarsdi (ustekinumab-aekn) Interleukin-12 and -23 antagonist Treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric [...]

Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox [...]

US News & World Report has released its new over-the-counter (OTC) medicine and health product rankings for 2024.The second annual Best OTC Medicine & Health Products list includes an additional [...]

Positive results were announced from a phase 3 study evaluating APL-1702 in cervical high-grade squamous intraepithelial lesion (HSIL). APL-1702 is an investigational, nonsurgical, single-use, photodynamic drug-device combination. The device automatically [...]

The table below is a review of notable updates that occurred in February 2024 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Allergic Disorders Xolair (omalizumab) Anti-immunoglobulin E (IgE) antibody For the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to 1 [...]

The Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS). PWS is a rare genetic disease characterized by severe hyperphagia [...]

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for vorasidenib for the treatment of isocitrate dehydrogenase- (IDH)-mutant diffuse glioma. Vorasidenib is an [...]

The American Academy of Dermatology (ADD) has issued updated guidelines on the management of acne vulgaris. The new guidelines include 18 evidence-based recommendations and 5 good practice statements resulting from [...]

The prescribing information for Dupixent[sup.®] (dupilumab) has been updated to include efficacy and safety data in patients 12 years of age and older with atopic dermatitis with uncontrolled moderate to [...]

The US Food and Drug Administration (FDA) approved a wide range of therapies in 2023, including many new molecular entities and biological products. The information below is organized by the [...]

The table below is a review of notable updates that occurred in December 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Dermatological Disorders Filsuvez (birch triterpenes) Botanical drug product (birch bark extract) Topical gel for the treatment of partial thickness wounds in patients 6 months [...]

The Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter regarding the New Drug Application (NDA) for etripamil nasal spray for the treatment of paroxysmal supraventricular [...]

Topical gel approved to treat partial thickness wounds in epidermolysis bullosa; Priority Review given to 21-valent pneumococcal conjugate vaccine; sensory and motor stimuli video game for ADHD gains expanded age [...]

Drug Pharmacologic Class Indication More Information Cardiovascular Disorders Adzynma (ADAMTS13, recombinant-krhn) Human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” Prophylactic or on-demand enzyme replacement therapy in adult and [...]

The table below is a review of notable updates that occurred in November 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

The table below is a review of notable updates that occurred in October 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Dermatological Disorders Bimzelx (bimekizumab-bkzx) Interleukin-17A and F antagonist Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or [...]

The Food and Drug Administration (FDA) has approved Penbraya[sup.™] (meningococcal groups A, B, C, W and Y vaccine), a pentavalent meningococcal vaccine for active immunization to prevent invasive disease caused [...]

The table below is a review of notable updates that occurred in September 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Infectious Diseases Likmez (metronidazole oral suspension) Nitroimidazole Treatment of trichomoniasis caused by Trichomonas vaginalis in adults, acute intestinal amebiasis and amebic liver abscess in [...]

It’s fair to say pharmacists have had a busy few years. Administering vaccines during a global pandemic would be hard enough, but they’ve also had to contend with a deluge [...]

Results from a confirmatory study evaluating sparsentan in patients with primary immunoglobulin A nephropathy (IgAN) showed that the treatment was associated with kidney function preservation when compared with irbesartan. In [...]

The table below is a review of notable updates that occurred in August 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Hematologic Disorders Reblozyl (luspatercept-aamt) Erythroid maturation agent Treatment of anemia in adults with very low- to intermediate-risk myelodysplastic syndromes who may require regular red [...]

The FDA and CDC greenlight updated COVID-19; prescription drug for dry eye disease now available; head-to-head study compares Skyrizi to Stelara for Crohn disease; the REMS program has been updated [...]

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for valbenazine oral granules, a new sprinkle formulation for the treatment of adults with tardive [...]

Xdemvy[sup.™] (lotilaner ophthalmic solution) is now available for the treatment of Demodex blepharitis. Xdemvy contains lotilaner, a gamma-aminobutyric acid-gated chloride channel inhibitor selective for mites. The product directly targets Demodex [...]

Drug Pharmacologic Class Indication More Information Cardiovascular Disease Injectafer (ferric carboxymaltose injection) Iron replacement product Treatment of iron deficiency in adult patients with heart failure categorized as New York Heart [...]

The table below is a review of notable updates that occurred in June 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

The table below is a review of notable updates that occurred in May 2023 for investigational products in development (not an inclusive list). Click on the status to view our [...]

Drug Pharmacologic Class Indication More Information Cardiovascular Disease Farxiga (dapagliflozin) Sodium-glucose cotransporter 2 inhibitor To reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visit [...]

The Food and Drug Administration (FDA) has approved Linzess[sup.®] (linaclotide) for the treatment of functional constipation (FC) in patients aged 6 to 17 years of age. Approval was based on [...]

The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for dostarlimab in combination with chemotherapy for the treatment of adults with mismatch repair deficient (dMMR)/microsatellite instability-high [...]

The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for tenapanor (Xphozah[sup.®]) for the control of serum phosphate in adult patients with chronic [...]

Drug Pharmacologic Class Indication More Information Hematological Disorders Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) Recombinant DNA-derived, Factor VIII concentrate Routine prophylaxis to reduce the frequency of bleeding episodes; on-demand [...]

IBSA Pharma Inc. announced the voluntary recall of 27 lots of Tirosint[sup.®]-SOL (levothyroxine sodium) oral solution to the consumer level due to subpotency. https://www.empr.com/drug/tirosint-sol/#thyroid-disease is indicated as replacement therapy in [...]

The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for Exxua[sup.™] (gepirone hydrochloride extended-release [ER]) for the treatment of major depressive disorder (MDD). Exxua (formerly [...]