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ALLMedicine™ Detailed topics Center - Drugs

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.

Gocovri Clinical Data
https://www.gocovrihcp.com/clinical-data/
Gocovrihcp.com

May 27th, 2020 - The efficacy and safety of GOCOVRI® 274 mg were evaluated in two Phase 3, randomized, placebo-controlled trials

Now Approved PHESGO™‎
https://www.phesgo.com/hcp.html

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

FINTEPLA® (fenfluramine) oral solution, CIV | For Dravet ...
https://www.finteplahcp.com/

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) Oral - Capsules Is Now FDA-Approved‎
https://hcp.mycapssa.com/

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® (decitabine and cedazuridine) tablets | Now Approved
https://www.inqovi.com/

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 ...

Find Safety, PI, Boxed Warning - Now Approved - HCP Site‎
https:// www.oriahnnhcp.com/

ORIAHNN® (elagolix/estradiol/norethindrone acetate and elagolix). View Dosing Information. View Safety Information. Financial Support Info. Official HCP Site.

Gimoti™ (metoclopramide) - Nasal Spray‎
https://www.gimotirx.com/

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.

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).

XYWAV™ Coming Soon - Treatment Information
https://xywav.com/hcp/

(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.

FDA-Approved Treatment - TECARTUS™ - tecartus.com
https://www.tecartus.com/hcp

(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.

Blenrep - Official HCP Website - View Prescribing Information
https://www.blenrephcp.com/

HCPs - Learn About Now Approved BLENREP (belantamab mafodotin-blmf). View Boxed Warning.

MONJUVI™ (tafasitamab-cxix) - Official HCP Website
https://www.monjuvihcp.com/

Learn More About MONJUVI, FDA-approved and Now Available. Visit the Official Site Now. Learn About Treatment. Treatment Calendar. Now Approved.

Semglee® | Insulin glargine injection | HCP Website
https://www.semglee.co.uk/en-gb

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.

Now Approved | MenQuadfi (Meningococcal [Groups A, C, Y, W and Y)
https://www.menquadfi.com/

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.

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.

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.

ZEPZELCA™ (lurbinectedin) - Now Approved Treatment‎
https://www.zepzelca.com/

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.