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RSS FeedPosted by Michael Wonder on 20 Jun 2017
Priority generic drug reviews: new FDA draft guidance
19 June 2017 - In preparation of its commitments under the second Generic Drug User Fee Amendments, the US FDA ...
Posted by Michael Wonder on 20 Jun 2017
When cholesterol drugs cost $14,000, an insurance tug-of-war
19 June 2017 - Patients struggle to obtain PCSK9 inhibitors, a powerful class of drugs that lower bad cholesterol in difficult ...
Posted by Michael Wonder on 20 Jun 2017
FDA grants fast track designation to Axovant's nelotanserin for visual hallucinations in dementia with Lewy bodies
19 June 2017 - Axovant Sciences today announced that the U.S. FDA has granted fast track designation to its investigational ...
Posted by Michael Wonder on 19 Jun 2017
The amount you pay for cancer drugs may double -- here's why
19 June 2017 - Cancer immunotherapies could push the price patients and insurers pay for cancer drugs through the roof. ...
Posted by Michael Wonder on 19 Jun 2017
How Trump can curb runaway drug prices
17 June 2017 - The president could use his deal-making skills to negotiate voluntary pricing restraints for the industry. ...
Posted by Michael Wonder on 19 Jun 2017
Despite pressure over prices, the drug industry is coasting on Capitol Hill
19 June 2017 - Less than six months ago, President Trump stood at a podium and roiled the pharmaceutical industry ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 19 Jun 2017
How did health care get to be such a mess?
19 June 2017 - The problem with American health care is not the care. It’s the insurance. ...
Posted by Michael Wonder on 18 Jun 2017
Fibrocell receives rare paediatric disease designation from FDA for FCX-013 for treatment of localised scleroderma
12 June 2017 - Gene therapy candidate under control of RheoSwitch therapeutic system technology is potential first-in-class treatment for chronic ...
Posted by Michael Wonder on 17 Jun 2017
Secrecy surrounding Senate health bill raises alarms in both parties
15 June 2017 - As they draft legislation to repeal the Affordable Care Act, Senate Republican leaders are aiming to ...
Posted by Michael Wonder on 17 Jun 2017
U.S. FDA approves Humalog Junior KwikPen for the treatment of diabetes
13 June 2017 - The U.S. FDA approved Eli Lilly and Company’s Humalog Junior KwikPen for the treatment of diabetes. ...
Posted by Michael Wonder on 17 Jun 2017
FDA science: working at the speed of emerging technologies
16 June 2017 - Let’s face it, we’ve all gotten used to nearly instant access to almost anything. ...
Posted by Michael Wonder on 17 Jun 2017
Ipsen announces FDA approval of Dysport (abobotulinumtoxin A) for the treatment of lower limb spasticity in adults
16 June 2017 - Ipsen today announced that the U.S. FDA has expanded the approved use of Dysport (abobotulinumtoxin A) ...
Posted by Michael Wonder on 17 Jun 2017
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
16 June 2017 - Darzelax (daratumumab) approved by U.S. FDA in combination with pomalidomide and dexamethasone for patients with multiple myeloma ...
Posted by Michael Wonder on 17 Jun 2017
Adamis wins U.S. approval to sell EpiPen rival, shares soar
15 June 2017 - Adamis Pharmaceuticals said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat ...