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U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy

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.

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma
https://www.fda.gov/drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-mantle-cell-lymphoma
FDA

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).

VEKLURY® (remdesivir) - FDA Approved
https://www.vekluryhcp.com/

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.

Riabni™ (rituximab-arrx) - FDA Approved Biosimilar
http://www.riabni.com/official_site/fda_approved

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.

PEPAXTO(Melphalan Flufenamide) - Learn About This Treatment
http://www.pepaxtohcp.com/

PEPAXTO® Now Approved Official Physician Site. Learn if it may be right for your patients. Patient Support resources. Prescribing information. Dosing and administration.

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
FDA

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.

FDA approves nivolumab for esophageal squamous cell carcinoma
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma
FDA

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.

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ramucirumab-plus-erlotinib-first-line-metastatic-nsclc
FDA

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.

U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19
https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

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.

FDA Drug Shortages - Sertraline
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

Kala Pharmaceuticals Announces FDA Approval of EYSUVIS™ for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
https://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-announces-fda-approval-eysuvistm-short-term

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...

Drugs@FDA: FDA-Approved Drugs
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
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.

Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients
https://clinicaltrials.gov/ct2/show/NCT04718480

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...

FDA approves niraparib for first-line maintenance of advanced ovarian cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer
FDA

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.

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-capmatinib-metastatic-non-small-cell-lung-cancer
FDA

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.

Retevmo™ (selpercatinib)‎ - Visit The Official Site‎
https://www.retevmo.com/

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.

CETRAXAL (ciprofloxacin otic solution)
http://www.cetraxal.net/

CETRAXAL is the first Food and Drug Administration (FDA) Ciprofloxacin single agent prescription ototopical antibiotic approved for the treatment of acute otitis externa in adults and children 1 year and older in the United States. CETRAXAL individual dosing vials make it easy for accurate dosing.

CORGARD® TABLETS (nadolol tablets, USP)
http://usworldmeds.com/wp-content/uploads/2017/08/CORGARD-PI-8.5x11.pdf

CORGARD (nadolol) is available for oral administration as 20 mg, 40 mg, and 80 mg tablets.

GAMMAKED™ (immune globulin injection (human))
http://www.gammaked.com/healthcare-providers/dosing-administration/

Learn about GAMUNEX-C as a treatment option for CIDP, PIDD, and ITP including its efficacy and safety information. GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified).

KOGENATE FS ANTIHEMOPHILIC FACTOR (recombinant)
https://www.kogenatefs.com/

Official site from Bayer. Learn about Kogenate® FS, Antihemophilic Factor (Recombinant), including uses, safety and administration information.