Search Results for “FDA” – Page 61 – media

FDA to Omit 501(k) Premarket Approval for Genetic Risk Tests

Today the FDA will officially exempt individual genetic risk tests from 501(k) premarket approval with the condition that the company offering the test should have a one-time premarket review of its testing apparatus and at least one test.
- Source: MobiHealthNews
- 711
- June 5, 2018
FDA genetic risk Market Views
FDA Seeking Digital Health to Combat Opioid Abuse

In November, FDA’s device center will select which app is welcomed into the program, and the selected will have amplified interactions with FDA during the progress of their products. FDA will grant the advanced device nomination to products that meet the permitted criteria without requiring a separate application.
- Source: Ddu
- 785
- June 1, 2018
digital health mHealth New Approvals opioid
New Cancer Drug Of Eisai And Merck Stalled By FDA

In a major setback for Eisai and Merck & Co, the FDA has stalled the roll-out of Lenvima as a treatment for earlier untreated liver cancer patients. Big things were expected by Merck & Co when Eisai’s Lenvima was scheduled to be launched in March. Merck has agreed to shell out USD 5.8 billion on half of the liver cancer’s drug sales.
- Source: Ddu
- 673
- May 28, 2018
FDA Merck New Approvals
FDA Warns Over Sunscreen Pills

Recently the FDA asked drug companies to stop selling sunscreen pills which and warned people not to fall for such scams as there are no pills which can replace sunscreen.
- Source: drugdu
- 706
- May 25, 2018
FDA Policies Sunscreen
Glenmark Files an Application to the USFDA for its Nasal Spray

The company informed that Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg), formerly GSP 301 Nasal Spray, has been conditionally accepted by the USFDA as the brand name.
- Source: Ddu
- 830
- May 22, 2018
Allergies FDA New Approvals
Aimovig a New Drug for Migraines Gets Approval from FDA

Aimovig, a ground-breaking drug to prevent Migraines was approved by the FDA last week. Aimovig will be the only player in the market to treat migraines. The new drug has to be taken once a month through an injection similar to an insulin shot or an EpiPen.
- Source: Ddu
- 641
- May 21, 2018
FDA migraine New Approvals
Trump calls for FDA price check with drug prices in ads

A particular proposal regarding displaying drug prices in TV ads flummoxed pharma marketers and ad agencies following the unveiling of the drug-pricing agenda by President Trump. Marketers have been hounded with the whys and hows of the proposal even as the administration remains firm on its implementation.
- Source: Ddu
- 804
- May 17, 2018
biopharmaceutical FDA pharma Policies
FDA Approves Qiagen’s PartoSure for Preterm Labor

On April 20, 2018, Qiagen announced the FDA approval of the novel test named PartoSureTM, used for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.
- Source: Ddu
- 634
- May 17, 2018
medical device New Approvals preterm labor
FDA approved Pfizer biosimilar Epogen/Procrits

The FDA granted approval to Pfizer for Retacrit (epoetin alfa-epbx), which is used for the treatment of anemia, biosimilar of Amgen, a drug which generated sales closely $ 1.8 billion in the U.S market last year for Amgen and Johnson & Johnson partners. Retacrit also received the go-ahead to be used in RBC transfusions by U.S health regulators.
- Source: Ddu
- 679
- May 16, 2018
anemia New Approvals Pfizer pharma
Plans unveiled by FDA for augmenting competition in drug markets

With the unveiling of a new drug price plan by the Trump Administration, the Food and Drug Administration (FDA) will put into action a plan to infuse competition in drug markets.
- Source: Ddu
- 351
- May 16, 2018

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