FDA – Page 20 – media

FDA approves first cancer biosimilar

The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
- Source: Pharmatimes
- 694
- September 18, 2017
biosimilar cancer FDA New Approvals
Checkpoint Therapeutics Receives Orphan Drug Designation for CK-101 for the Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT)'s Orphan Drug Designation to CK-101 (also known as RX518), the Company’s third-generation epidermal growth-factor receptor (EGFR) inhibitor, for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 514
- September 12, 2017
FDA inhibitor NSCLC
FDA sends damning warning letter to Pfizer after misfiring EpiPens linked to deaths

The US Food and Drug Administration(FDA) has sent a damning warning letter to drug giant Pfizer Inc (NYSE:PFE) after it received “hundreds of complaints” that the anti-allergy EpiPen device misfired “during life-threatening emergencies”.
- Source: Proactiveinvestors
- 708
- September 11, 2017
anti-allergy FDA
Sanofi wins tentative FDA nod for Admelog insulin lispro injection

Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
- Source: yahoo
- 749
- September 7, 2017
Company Insight diabetes FDA insulin New Approvals
FDA approves Adherium’s new inhaler monitoring device

The US Food and Drug Administration (FDA) has cleared Adherium for its new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
- Source: medicaldevices-business-review
- 585
- September 5, 2017
Company Insight FDA inhaler respiratory
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
- Source: biospace
- 573
- September 5, 2017
cancer FDA follicular lymphoma New Approvals sBLA
FDA approves Teva’s Austedo for tardive dyskinesia

Teva’s Austedo is now the first and only therapy approved in the US to treat both tardive dyskinesia and chorea associated with Huntington’s disease.
- Source: news.open-medical
- 672
- September 1, 2017
chorea FDA New Approvals tardive dyskinesia Teva
FDA approves Malin’s Hourglass peripheral embolization plug

FDA has cleared Irish life sciences company Malin Corp for its Hourglass peripheral embolization plug.
- Source: massdevice
- 566
- August 23, 2017
Company Insight embolization FDA New Approvals peripheral
J&J’s Ethicon launches ProxiSure laparoscopic suturing device

The ProxiSure laparoscopic suturing device was launched, said Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon.
- Source: massdevice
- 526
- August 22, 2017
Company Insight FDA laparoscopic suturing
US regulators wave through Pfizer’s leukaemia drug

Pfizer’s Besponsa has been approved by the US Food and Drug Administration (FDA). It's the first and only CD22-directed antibody-drug conjugate indicated to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
- Source: pharmatimes
- 1,064
- August 21, 2017
ALL antibody Company Insight FDA New Approvals

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