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About 259,186 results

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.

Lisinopril Drug Facts & Guidance
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf
FDA

Early indicators: Investigational convalescent plasma is safe for patients with COVID-19
https://newsnetwork.mayoclinic.org/discussion/early-indicators-investigational-convalescent-plasma-is-safe-for-patients-with-covid-19/

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...

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).

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...

Prescription Drug Pricing Transparency Law Comparison Chart
https://www.nashp.org/prescription-drug-pricing-transparency-law-comparison-chart/
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...

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.

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.

ACTIQ® (fentanyl citrate
http://www.actiq.com/

INDICATIONS AND USAGE. ACTIQ® oral transmucosal lozenge, CII is indicated for the management of breakthrough pain in cancer patients 16 years of age

ADCETRIS® (brentuximab vedotin)
http://adcetrisupdate.com/

Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma.

ASTAGRAF XL® (tacrolimus)
http://astagrafxl.com/

ASTAGRAF XL, the once-daily anti-rejection drug for kidney transplant patients. Please see complete Prescribing Information, including boxed warning.

BELBUCA® (buprenorphine) buccal film
https://www.belbuca.com/hcp/

BELBUCA® (Buprenorphine) is the first oral formulation of buprenorphine proven to deliver consistent analgesia and tolerability. Rethink Relief.

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.

BUSULFAN INJECTION
http://www.sagentpharma.com/wpcproduct/busulfan-injection/

Busulfan Injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)