New Approvals – Page 20 – media

FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
- Source: Gene
- 558
- December 8, 2017
FDA Genentech New Approvals Roche
Lilly’s Taltz cleared to treat psoriatic arthritis

US regulators have expanded the scope of Eli Lilly’s plaque psoriasis drug Taltz to include the treatment patients with psoriatic arthritis.
- Source: Pharmatimes
- 486
- December 6, 2017
New Approvals plaque psoriasis Taltz
FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration (FDA) today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.
- Source: mdlinx
- 628
- December 5, 2017
breast cancer FDA herceptin New Approvals Ogivri stomach cancer
FDA Clears First Medical Device Accessory for Apple Watch®

Atrial Fibrillation (AFib), is the most common heart arrhythmia, and a leading cause of stroke. AFib affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. Millions of people around the world are unknowingly living with AFib. Yet, two out of three strokes are preventable when AFib is detected and treated appropriately.
- Source: Prnewswire
- 540
- December 4, 2017
AI Apple Watch New Approvals
Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority

Review Designation of Mogamulizumab’s Biologics License Application
- Source: drugdu
- 480
- November 29, 2017
Biologics License Application FDA New Approvals
China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
- Source: Gilead
- 775
- November 27, 2017
CFDA Gilead Sciences HCV New Approvals Sovaldi®
FDA approves first two-drug regimen for certain patients with HIV

The U.S. Food and Drug Administration(FDA) today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.
- Source: finance.yahoo
- 474
- November 22, 2017
FDA HIV immunodeficiency Juluca New Approvals
FDA OKs Genentech’s Gazyva for Untreated Follicular Lymphoma

Twice on Thursday, Genentech, scored two approvals from the U.S. Food and Drug Administration(FDA) – a new medicine for hemophilia and an expansion for its cancer drug Gazyva.
- Source: Biospace
- 594
- November 21, 2017
cancer FDA hemophilia lymphoma New Approvals
FDA approves new treatment Hemlibra (emicizumab-kxwh) to prevent bleeding in certain patients with hemophilia A

The U.S. Food and Drug Administration(FDA) approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
- Source: pharmacist
- 744
- November 20, 2017
FDA Hemlibra hemophilia inhibitor New Approvals
Salt raises blood pressure, but our gut bacteria can stop it

It's a known fact that too much salt can increase blood pressure. But new research brings gut bacteria into the mix, and some good news along with it: probiotics may help to reverse the harmful effects of excessive salt.
- Source: medicalnewstoday
- 707
- November 17, 2017
blood pressure cardiovascular gut bacteria New Approvals

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