The remdesivir clinical trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID-19 patients.
Gocovri Prescribing Information, PI, Parkinson Disease, PD
Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
May 27th, 2020 - The efficacy and safety of GOCOVRI® 274 mg were evaluated in two Phase 3, randomized, placebo-controlled trials
Mayo Clinic and collaborators today reported safety data on the first 5,000 hospitalized patients transfused with investigational convalescent plasma as part of the Food and Drug Administration’s national Expanded Access Program (EAP) for COVID-19. The early indicators suggest experimental convalescent plasma is safe in treating severely ill patients. At this time, convalescent plasma is the on...
Info on PHESGO™(pertuzumab/trastuzumab/hyaluronidase-zzxf), See Safety & Boxed Warning. Newly Approved Treatment · Get Info on Dosing · Downloads Available Types: Prescribing Info, Product Guide, Downloadable Brochure
Dojolvi is indicated 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 (LC-FAOD).
FINTEPLA is a prescription medicine used to treat the seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA is a federally controlled substance (C-IV) because it contains fenfluramine. Keep FINTEPLA in a safe place to prevent misuse, abuse, and protect it from theft.
MYCAPSSA® (octreotide) delayed-release oral capsules is the first and only FDA-approved oral somatostatin analog (SSA) for appropriate patients with acromegaly, providing effective and consistent biochemical control, while freeing patients from the burden of injections.
INQOVI is the first and only oral hypomethylating agent (HMA) indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic ...
ORIAHNN® (elagolix/estradiol/norethindrone acetate and elagolix). View Dosing Information. View Safety Information. Financial Support Info. Official HCP Site.
Learn about FDA-approved Gimoti. See Safety and Boxed Warning. Get updates and read about Gimoti, a different formulation of metoclopramide. Prescribing Information. Press Release. Important Safety Info.
Qwo™ (collagenase clostridium histolyticum-aaes) Is Now FDA Approved. Check Out The Press Release & Sign Up For More Information From Endo Aesthetics Today. Official Product Site · Sign Up For Updates · Indication
Jul 23rd, 2020 - The Food and Drug Administration granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
(Calcium, Magnesium, Potassium & Sodium Oxybates). See Prescribing Info and BOXED Warning. Discover XYWAV Coming Soon. Sign Up To Receive Treatment and Safety Information Today. Availability Updates. Sign Up. Safety Information. Medication Guide.
(Brexucabtagene Autoleucel) Visit Site To Learn More & Read Important Warnings. Download The Medication Guide And Find Your Nearest Treatment Center. Important Warnings. Download Med Guide. Find A Center.
HCPs - Learn About Now Approved BLENREP (belantamab mafodotin-blmf). View Boxed Warning.
Learn More About MONJUVI, FDA-approved and Now Available. Visit the Official Site Now. Learn About Treatment. Treatment Calendar. Now Approved.
(budesonide/glycopyrrolate/formoterol fumarate) Now Approved. Visit The Physician Site. Explore A New Approved Treatment Option. Be The First To Learn About BREZTRI. Now Approved. Prescribing Information. Register For Updates. Learn The Pronunciation.
Learn More About VEKLURY® as an FDA Approved Treatment Option for Eligible Patients. Product Access Information and Resources for HCPs are Available Here. Product Access. Register for Updates. Dosing & Administration. HCP Resources. Patient Support for HCPs.
Helpful information for your patients. Get product information intended for healthcare professionals. Resources. About KALYDECO. Studies and Data.
Visit The Official HCP Website for GAVRETO Information. Learn More Today. Safety Information. Registration Form. Patient Services. HCP Information. Patient Support. Dosing Information. Downloadable Resources. Healthcare Professionals. Prescribing Information.
Learn about an FDA-approved continued treatment option for patients with AML in remission. Register to receive updates. See safety info & full Prescribing Info.
To Learn More, Visit XARACOLL.com · A portfolio company of. Gurent Point Capital. Innocoll Logo. Business Development Group Unit 9, Block D Monksland ...
TEPEZZA is a prescription medicine for the treatment of Thyroid Eye Disease (TED), also known as Graves' Orbitopathy. See safety information.
KESIMPTA® is FDA Approved. Download a Start Form Today. Visit Now to Learn More. Access PI and Start Resources for HCPs. Contact Us for Support. Enrollment Support. Official HCP Website. HCP Resources. FDA Approved. KESIMPTA® Safety Info.
Visit Official HCP Site to See if Evrysdi™ Could be an Option for Your Patients. Evrysdi Challenges. Evrysdi Education. Evrysdi Resources. Evrysdi Treatment. Types: Learn About Evrysdi, Clinical Trial Results, Safety and Efficacy, Potential Benefits.
CYSTADROPS (cysteamine ophthalmic solution) 0.37% is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
Explore ENSPRYNG™ As A New Treatment Option For Your Patients. Contraindications. Prescribing Information. Safety Info. Dosing & Admin. Types: Financial Assistance, ENSPRYNG Access Solutions, Clinical Trial Data, Patient Resources.
VILTEPSO is a treatment for Duchenne muscular dystrophy (DMD) in patients amenable to exon 53 skipping. Learn more about the clinical benefits.
Zokinvy (lonafarnib) now FDA approved for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid ...
For Rheumatologists and Nephrologists: See LUPKYNIS™ prescribing info and boxed warning. Learn more about this new FDA approved medication. Register for Updates · Contact a Rep · Prescribing Information
Learn About The TG Patient Support™️ Program To Help Your Patients Access UKONIQ™️. Find Out More About UKONIQ™️, An Exciting New Treatment Option For Your Patients. Prescribing Information. About UKONIQ™️. Professional Resources. TG PatientSupport™️.
Breyanzi® (lisocabtagene maraleucel) - See Boxed Warning, Full Safety & Prescribing Info. A New Treatment Option That May Help Your Patients. Get the Info You Need.
Attention Physicians - View Important Information On CABENUVA Injectable Suspensions. Educational Resources. Clinical Trial Results. Types: Official HCP Site, Prescribing Info.
HCPs - Now Approved - EVKEEZA™ (evinacumab-dgnb)
Visit the Site to Register and Receive the Info You Need For This Once-Daily Treatment. Coming Soon: The Once-Daily Treatment PONVORY™. Sign Up For More Information! For HCPs. Coming Soon. Sign Up for More Info.
Discover why NULIBRY may be an option for your patients. Learn about NULIBRY Dosing. FDA-Approved. Find out more. Services: Patient Support Program, Patient Access Program, Dosing Guide.
Get Safety Info & Boxed WARNINGS. View Support and Resource Information. Amgen Expertise. Patient & Caregiver Info. Storage And Handling. Prescribing Information. Request An Oncology Rep. Totality Of Evidence. Patient Support. Dosing And Administration.
Download The COSELA Package Insert For Information. Visit The Website For Clinical Trial Results & Dosing Guidelines. Therapy Efficacy. Important Safety Info. Prescribing Information. Dosing Information.
PEPAXTO® Now Approved Official Physician Site. Learn if it may be right for your patients. Patient Support resources. Prescribing information. Dosing and administration.
Info On ABECMA® As A Treatment Option. See full safety, PI, & Boxed Warnings. Info on New Potential Treatment Option. See full safety, PI, & Boxed Warnings. FDA-Approved. Caregiver Information. Treatment Study Results. Patient Resources. Safety Information.
Semglee® is an approved biosimilar of reference insulin glargine. It is indicated for treatment of diabetes mellitus in adults, adolescents & children over 2 years of age.
Learn more about the mechanism of action of QINLOCK. Request more information today. Download the QINLOCK clinical efficacy and safety overview for healthcare professionals. Resources. Support Your Patients. View Dosing Information. FDA Approved. Clinical Data.
MenQuadfi is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidisserogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N. meningitidisserogroup B disease.
HCPs: Trijardy® XR (empagliflozin/linagliptin/metformin HCl extended release tablets). Dosing Information. Helpful Resources. Patient Coverage. Types: Savings Program, Information, Resources, MOA.
Jun 14th, 2020 - On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin(ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Jun 9th, 2020 - On June 10, 2020, the Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Learn About Now Approved ZEPZELCA On The Official Patient Website Today. Patient Information. Prescribing Info. Safety Profile Info. Resources & Support. Now FDA Approved. Treatment Information. Important Safety Info.
On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization.
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sertraline Hydrochloride Tablets&st=c&tab=tabs-4&panels=1
US Food and Drug Administration
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 27, 2020-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two...
Visit A Site For Healthcare Professionals To Learn Important Information On Pemazyre. Discover A Treatment Option For Your Patient And Read About The Usage And Indications. Recommended Dosing. Safety Profile. Clinical Response Rates. Prescribing Information.
Overdose of EMERPHED can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.
Request a Rep Visit, or Register to Get Updates & Stay Informed About TUKYSA™ Today. Prescribing Information. Now Approved. Learn More. Official Physician Site.
ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Limitation of Use: ...
BARHEMSYS® is now approved! Read the press release and register for updates. Learn more.
Official Site: Learn about TRODELVY™, Clinical Study Results. FDA approved. See Full Safety and Prescribing Information including boxed Warning. Prescribing Information. Safety. Dosing. Financial Support.
HCPs: Learn about a now-approved treatment option for your patients. Discover ONGENTYS. Sign up to receive updates about ONGENTYS. View Press Release. Contact a Rep. See Full PI. Now Approved. See Full PI. View Press Release. Sign Up for Updates.
Learn More Information About Now FDA-Approved KOSELUGO On The Official Site. Resources Available. Important Safety Info. Indication Info. Download Prescribing Info. Access 360 Program. Insurance coverage: Financial Support Info, Access 360 Program.
Read More Information About JELMYTO™ (mitomycin) for pyelocalyceal solution. Dosing Information. Healthcare Professionals. Key Clinical Data.
PALFORZIA is the first and only FDA-approved oral immunotherapy for peanut allergy in patients aged 4 through 17 years.
The National Academy for State Health Policy (NAHSP)
A number of states have enacted drug pricing transparency laws requiring drug supply chain entities such as manufacturers, pharmacy benefit managers, health plans, and others to report information explaining high price increases and high-priced new drugs. This chart compares states’ transparency laws, each tab provides an overview of required reporting from specific supply chain entities. To le...
US Food and Drug Administration (FDA)
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
Jan 21st, 2021 - This is a randomized, double-blind, placebo-controlled, adaptive two-stage design, human phase 2 study, with add-on treatment arrangement of fluvoxamine or placebo on top of standard of care (base therapy: the actual proposed therapy of moderate SARS-CoV-2 infected patients according to "Hungarian Coronavirus Handbook", including antiviral and immunmodulant therapy and reconvalescent plasma the...
Eli Lilly and Company
Mar 9th, 2021 - INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients recently diagnosed with CO...
Apr 28th, 2020 - The Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
May 5th, 2020 - On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
View Safety & Prescribing Information On The Official Patient Site. Learn How Retevmo™ Works And How It May Help Eligible Patients. Savings & Support. Dosing and Administration. About RETEVMO™. Types: Patient Resources, Treatment Information, Safety Information.
(daratumumab and hyaluronidase human-fihj) Learn More at the Official Physician Site. Prescription Assistance. Patient Support Program. Dosing Admin & Safety. Janssen CarePath. Official Physician Site. Learn About Multiple MOAs. Patient Dosing Schedule.
HCPs, Visit The Official Site For Information About TABRECTA™ As A Treatment Option. See If TABRECTA™ Could Be Right For Your Patients. Full Safety Profile. Patient Co-Pay Program. Mechanism Of Action. Newly FDA Approved. Official HCP Website. Clinical Trial Data.
ACT® Dry Mouth | ACT® Anticavity Fluoride Rinse
ACT® Advanced Care™ Plaque Guard™ | ACT® Anticavity Fluoride Rinse
CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
ACT® Adult Fluoride Mouthwash | ACT® Anticavity Fluoride Rinse
Adempas (riociguat). Visit Adempas-US.com to see full safety and prescribing information, including Boxed Warning. Learn about Adempas and the Aim Patient Support Program.
Acnizil™ is a new first-line therapy product for mild to severe acne. It is made from a proprietary silver solution
An in vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs)
Find valuable ACTEMRA® (tocilizumab) information, including an ACTEMRA® dosing calculator, RA patient brochure, ACTEMRA® prescription guide and the ISI. IMPORTANT SAFETY INFORMATION-RA: ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist.
Explore AcrySof IQ intraocular lenses for your cataract surgery and the AcrySof® Advantage at myalcon.com.
Learn about Adlyxin™ (lixisenatide) injection, a GLP-1 receptor agonist to help improve glycemic control in adults with type 2 diabetes indicated as an adjunct to diet and exercise.
ABILIFY MAINTENA for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in adult patients. See full Safety and Prescribing Information, including BOXED WARNING.
ADCIRCA is a trademark of Eli Lilly and Company. http://pi.lilly.com/us/adcirca-ppi.pdf. Please see Important Safety Information and Full Prescribing Information.
The first and only FDA-approved treatment indicated to slow kidney function decline and kidney cyst growth in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
ACTICLATE® (doxycycline hyclate USP) Tablets are indicated for adjunctive therapy in severe acne. Click here for Full Prescribing Information for ACTICLATE® Tablets. Important Safety Information Regarding ACTICLATE® (doxycycline hyclate USP) Tablets, 150 mg and 75 mg.
The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area
ADDERALL XR, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
INDICATIONS AND USAGE. ACTIQ® oral transmucosal lozenge, CII is indicated for the management of breakthrough pain in cancer patients 16 years of age
Find information on Adzenys XR-ODT delivery system, dosing, adverse reactions, and safety data. Learn about savings and support available to your patients. View Important Safety Information including Boxed WARNING for abuse and dependence.
Discover how ADDYI increased sexual desire and decreased associated distress in premenopausal women with acquired, generalized HSDD. See full safety info.
Find ACZONE® Gel dosage, side effects, efficacy, patient savings program, and pivotal trial information all in one place. View important safety information.
Adrenaclick (epinephrine injection, USP auto-injector) is an emergency injection (shot) of epinephrine used for the treatment of life-threatening allergic reactions known as anaphylaxis. With numbered and color-coded instructions, Adrenaclick is designed for single-dose use by patients and caregivers in an anaphylactic
Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body ...
AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults
Reduce the swelling caused by nasal inflammation to breathe easier with Advil® Cold & Sinus