ALLMEDx | *:*

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.

Package Insert - COSELA™ (trilaciclib)
http://www.cosela.com/

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(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.

ABECMA® | (idecabtagene vicleucel)
https://www.abecmahcp.com/

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® | 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.

QINLOCK (ripretinib) - Health Care Professional Site‎
https://www.qinlockhcp.com/

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.

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.

Trijardy XR - Boxed Warning & Safety Info - Official HCP Website‎
https://www.trijardyxrhcp.com/?

HCPs: Trijardy® XR (empagliflozin/linagliptin/metformin HCl extended release tablets). Dosing Information. Helpful Resources. Patient Coverage. Types: Savings Program, Information, Resources, MOA.

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.

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...

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.

Anjeso(TM) (meloxicam) injection home page I Now approved
https://www.anjeso.com

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
https://barhemsys.com/

BARHEMSYS® is now approved! Read the press release and register for updates. Learn more.

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