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FDA

Showing 15 posts of 1442 posts found.

fda2outsideweb

Trump’s FDA pick vows to sever past pharma ties to avoid partisanship

March 30, 2017
Medical Communications, Sales and Marketing FDA, Scott Gottlieb, Trump

After much speculation, Donald Trump recently announced his top pick for Commissioner of the FDA as Dr Scott Gottlieb. Gottlieb …

News
novartis_outside_1

Novartis investigational CAR-T therapy gets FDA priority review

March 30, 2017
Sales and Marketing CTL019, FDA, Novartis, leukaemia

Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy CTL019 (tisagenlecleucel-T) has been awarded has been awarded priority review by …

News
fda2outsideweb

FDA approves first Parkinson’s treatment in a decade

March 22, 2017
Research and Development, Sales and Marketing FDA, Parkinson's, Xadago

The FDA has approved Xadago (safinamide) as a supplementary treatment for Parkinson’s in patients currently taking levodopa/carbidopa and who are …

News
water-243910_960_720

FDA warns API manufacturer about river water as ingredient

March 17, 2017
Manufacturing and Production, Medical Communications Badrivishal Chemicals & Pharmaceuticals, FDA, India

The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes. The most worrying …

News
blood-1813410_960_720

AstraZeneca hit with second blow on $2.7 billion drug

March 17, 2017
Medical Communications AstraZeneca, FDA, hyperkalaemia

AstraZeneca paid $2.7 billion for ZS Pharma, back in 2015, with the desire to get its hands on the company’s …

News
china-pharmaceutical-industry

FDA warns China’s Lumis over misbranded APIs

March 16, 2017
Manufacturing and Production FDA, Lumis

Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning …

News
fdaoutsideweb

Trump’s proposed budget doubles FDA regulatory fees

March 16, 2017
Sales and Marketing FDA, Trump

Trump’s presidency could cost the industry more than twice as much in regulatory review fees next year, as his administration …

News
shutterstock_156022646

FDA-approved preterm birth drug has no benefit and may cause harm, study suggests

March 15, 2017
Research and Development FDA, Makena

A study by the UT Southwestern Medical Center has found that the synthetic progestogen hormone 17-alpha hydroxyprogesterone caproate (17-OHPC), a …

News
sun_pharma

FDA lifts block on Sun Pharma facility

March 14, 2017
Manufacturing and Production FDA, Sun Pharma

Sun Pharma has announced that the FDA informed it that the Import Alert in place upon its Mohali manufacturing facility …

News

Trump makes choice on new FDA head

March 13, 2017
Medical Communications, Sales and Marketing FDA, Gottlieb, Trump

Dr. Scott Gottlieb is Trump’s chosen nominee for the role of commissioner of the FDA. The nomination appeases fears within …

News
facilities_lg06

13 FDA observations on Dr Reddy’s plant send shares to 3 year low

March 9, 2017
Manufacturing and Production Dr Reddy's, FDA

Indian pharmaceutical firm Dr Reddy’s has seen its shares drop on the Bombay Stock Exchange to their lowest point in …

News
amgen_hq

FDA and NICE approve of first new hyperparathyroidism drug in 12 years

March 8, 2017
Research and Development, Sales and Marketing FDA, NICE, Parsabiv, hyperparathyroidism

The FDA has given the go-ahead for Amgen’s hyperparathyroidism (HPT) therapy Parsabiv (etelcalcetide), marking the first new treatment for patients …

News
sink

FDA approves first treatment for excessive night-time urination

March 6, 2017
Manufacturing and Production FDA, Noctiva, Serenity

The FDA has approved Noctiva, administered as a nasal spray, for the treatment of people suffering from nocturnal polyuria – …

News
eu_and_fda

EU-US reach landmark deal on mutual recognition of manufacturing inspection

March 3, 2017
Medical Communications EMA, EU, FDA, US

The European Union and the US has announced that an agreement has been made to mutually recognise inspection of drug …

News

FDA green lights AstraZeneca type-2 diabetes drug

February 28, 2017
Manufacturing and Production, Sales and Marketing AstraZeneca, FDA

AstraZeneca has announced that its type-2 diabetes treatment Qtern (10mg dapagliflozin and 5mg saxagliptin) has received the approval of the …

News
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