FDA – Page 5 – media

Hospira Inc. Recalls Opioid Antidote Naloxone

According to the FDA, if the antidote drugs are used on a patient, they could suffer from “allergic reactions, local irritation” and a wide number of cardiovascular issues, including restriction of blood supply to tissues. The FDA stated that there has not yet been any reports of patient harm from Naloxone.
- Source: Ddu
- 608
- June 7, 2018
Company Insights FDA opioid
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
- 714
- June 5, 2018
FDA genetic risk Market Views
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
- 679
- 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
- 716
- 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
- 837
- 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
- 644
- 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
- 810
- May 17, 2018
biopharmaceutical FDA pharma Policies
Amsterdam airport to be a new site for EU CAR-T manufacturing facility of Gilead

When it comes to manufacturing CAR T drugs (personalized treatments engineering immune cells to destroy cancer cells of patients) speed is of utmost importance. A new manufacturing site has been decided upon by Gilead for Yescarta, its CAR-T therapy at a Netherlands airport.
- Source: drugdu
- 665
- May 16, 2018
cancer CAR T-cells FDA New Approvals
FDA Approves CAR T Therapy for Large B-Cell Lymphoma Developed at University of Pennsylvania

Nation’s first approved personalized cellular therapy now available for second indication
- Source: pennmedicine.org
- 528
- May 8, 2018
B-cell lymphoma FDA Kymriah
FDA approve iSchemaView’s 3D CTA

iSchemaView has received FDA approval for its latest product, RAPID CTA, a 3D imaging platform for computed tomography angiography (CTA).
- Source: drugdu
- 3,548
- May 4, 2018
digital health FDA imaging New Approvals

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