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Showing 15 posts of 1442 posts found.

fda2outsideweb

Egalet gains FDA approval for difficult to abuse painkiller

January 10, 2017
Manufacturing and Production, Research and Development, Sales and Marketing Arymo ER, Egalet Corp, FDA

Egalet has gained FDA approval for Arymo ER, a long-acting opioid painkiller that is made to be difficult to breakdown. …

News
wockhardt_hospital_mumbai

Wockhardt’s Gujarat plant hit with FDA warning letter

January 5, 2017
Manufacturing and Production FDA, Wockhardt

Indian pharma and biotech firm Wockhardt has been accused of violating current good manufacturing practice (CGMP) regulations in a letter …

News
pregnancy

Morning sickness pill scientific backing called into question

January 5, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Diclectin, Diclegis, Duchesnay, FDA, kim kardashian, morning sickness

Many women suffer from morning sickness during the early stages of pregnancy and some suffer from hyperemesis gravidarum, acute morning …

News
sheep

FDA steps up fight against superbugs with livestock ruling

January 5, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Antibiotics, FDA, Guidelines, Livestock, agriculture, antibiotic resistance, farmers

The FDA began the year by announcing the implementation of ‘Guidance for Industry #213’. The new rule is a voluntary …

News
texas-star

Texas launches lawsuit against FDA over lethal drug shipment

January 4, 2017
Medical Communications, Research and Development FDA, texas

The state of Texas has filed a lawsuit against the FDA to try to force a decision to be made …

News

Biogen’s gains late-year drug approval first for controversially expensive drug

January 3, 2017
Manufacturing and Production, Sales and Marketing Biogen, FDA

The FDA squeezed in one last approval before the year ended with the first approval for a drug to treat …

News
fdaoutsideweb

FDA new drug approvals sink to six year low

December 21, 2016
Medical Communications, Research and Development FDA, NDA, new drug approvals

The FDA has released figures to show that drug approvals have fallen from last year’s high of 45 new drugs …

News
fda2outsideweb

FDA orders new label warnings over anaesthetics risk in children

December 19, 2016
Research and Development, Sales and Marketing FDA, anaesthetics

The FDA has announced a new Drug Safety Communication for label warnings on general anaesthetic and sedation products because of …

News
digital_pharma

NICE and FDA to collaborate in medtech access scheme

December 15, 2016
Medical Communications, Sales and Marketing FDA, NICE

The National Institute of Health and Care Excellence (NICE) and the US Food and Drugs Administration (FDA) have announced their …

News
sun_pharma

Sun Pharma’s Halol plant’s leaky roof irks FDA

December 13, 2016
Manufacturing and Production FDA, Sun Pharma, inspection

The FDA’s two week inspection of Sun Pharmaceutical’s Halol plant produced a 14-page report, with some criticisms reserved for poorly …

News

FDA approves another indication for Lilly/Boehringer diabetes treatment

December 5, 2016
Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, jardiance

Jardiance (empagliflozin), an oral SGLT02 inhibitor developed by Eli Lilly and distributed by Boehringer Ingelheim, has been approved by the …

News
humira_abbott_

Humira biosimilar proves efficacy in Phase 3 trial

November 30, 2016
Research and Development AbbVie, Amgen, FDA, Humira, M923, Momenta

US-based biotechnology firm Momenta Pharmaceuticals has announced that its biosimilar version of Abbvie’s autoimmune drug Humira (adalimumab) – currently the …

News
shutterstock_204190579

MDMA trials get FDA backing for PTSD treatment

November 30, 2016
Research and Development FDA, MDMA, PTSD

The FDA have given the go-ahead to Phase 3 clinical trials investigating the efficacy of MDMA (Methylenedioxymethamphetamine) for treating post-traumatic …

News
wockhardt_hospital_mumbai

Wockhardt UK sterile site hit with FDA warning

November 29, 2016
Manufacturing and Production FDA, Wockhardt, Wrexham

Mumbai-based pharmaceutical and biotechnology firm Wockhardt has been hit with more manufacturing woes as the FDA issued a warning letter …

News

FDA orphan drug designation doubles PhaseRx shares

November 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Orphan Drug Designation, PhaseRx

PhaseRx is celebrating as its lead drug candidate PRX-OTC has been orphan drug designation by the US FDA for the …

News
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