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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.

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.

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.

Pemazyre™ (pemigatinib) - Official Pemazyre HCP Website‎
https://hcp.pemazyre.com

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.

Emerphed | The first and only FDA approved ready-to-use ephedrine
https://www.emerphed.com

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.

TUKYSA™ (tucatinib) tablets - Information for Physicians‎
https://www.tukysahcp.com

Request a Rep Visit, or Register to Get Updates & Stay Informed About TUKYSA™ Today. Prescribing Information. Now Approved. Learn More. Official Physician Site.

Now Approved: TRODELVY™ - Sacituzumab Govitecan-hziy‎
https://www.trodelvy.com

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.

KOSELUGO™ (selumetinib) - Official Website‎
https://www.koselugo.com

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.

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.