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Showing 15 posts of 1445 posts found.

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FDA determines Xiamen Origin Biotech wilfully lied to inspectors and customers

August 4, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Xiamen Origin Biotech

The US Food and Drug Administration (FDA) carried out an inspection of Chinese drug manufacturer  Xiamen Origin Biotech, finding the …

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novartis_building

Breakthrough therapy designation for Novartis in advanced breast cancer treatment

August 3, 2016
Research and Development, Sales and Marketing Breakthrough Therapy Designation, FDA, LEE011, Novartis, ribociclib

Novartis has announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation to LEE011 (ribociclib) …

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FDA approves Shire’s haemophilia A treatment system

August 1, 2016
Manufacturing and Production, Research and Development FDA, Shire, adynovate, baxject, haemophilia

Shire has announced that the Food and Drug Administration (FDA) has approved the baxject III reconstitution system for adynovate [antihemophilic …

News

Surprise for Seres as shares sent tumbling by Phase II failure

August 1, 2016
Research and Development, Sales and Marketing FDA, clostrodium difficile, seres therapeutics

Seres Therapeutics has presented interim results from an ongoing Phase II trial which has sent company stock spiralling downward, as …

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antiviralresearch

FDA fast tracks Shire’s SHP626 nonalcoholic steatohepatitis drug

July 29, 2016
Research and Development FDA, SHP626, Shire, liver fibrosis, nash, volixibat, volxibat

The Food and Drug Administration (FDA) has granted Fast Track designation to Shire’s SHP626 (volixibat) treatment for patients suffering from …

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Sanofi gets FDA approval for type-2 diabetes treatment Adlyxin

July 28, 2016
Research and Development, Sales and Marketing FDA, Lixisenatide, Lyxumia, Sanofi, adlyxin, approval, diabetes, type 2, type-2, zealand

Sanofi has announced that the US Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), which is a once-daily mealtime …

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Darzalex receives breakthrough designation in multiple myeloma from FDA

July 26, 2016
Manufacturing and Production, Research and Development FDA, Genmab, Janssen, darzalex, multiple myeloma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Darzalex (daratumumab) in combination with standard of …

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needles

Valeant receives complete response letter from FDA on glaucoma drug

July 22, 2016
Medical Communications, Sales and Marketing FDA, Glaucoma, Valeant

Valeant Pharmaceuticals has announced that it has received a complete response letter from the FDA rejecting their new drug application …

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merckwindow

MSD faces delay in C. diff drug approval as FDA requests more data

July 22, 2016
Medical Communications, Research and Development C diff, FDA, MSD, Merck

MSD, known as Merck in the US and Canada, has received a setback in its bid to get new C. …

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Pfizer and Spark Therapeutics granted FDA breakthrough designation for haemophilia drug

July 22, 2016
Medical Communications, Research and Development FDA, Pfizer, Spark Therapeutics, haemophilia B, spk-9001

Pfizer and Spark Therapeutics have announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation …

News
astrazeneca_crestor_rosuvastatin_40mg

AstraZeneca loses legal bid to block Crestor generics

July 20, 2016
Research and Development, Sales and Marketing AstraZeneca, Crestor, FDA, generics, legal

A US district court judge has refused AstraZeneca’s request for a temporary restraining order blocking the approval of generic versions …

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doc_writing

FDA panel unanimously recommends approval of Valeant’s brodalumab with conditions

July 20, 2016
Research and Development, Sales and Marketing FDA, Valeant, brodalumab

Valeant has announced that the US Food and Drug Administration’s (FDA) dermatologic and ophthalmic drugs advisory committee has recommended brodalumab …

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opdivo_1

Opdivo to go before EU, US regulators in head and neck cancer

July 19, 2016
Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo

Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …

News

FDA approves first extended depth of focus lenses for people with cataracts

July 18, 2016
Research and Development, Sales and Marketing Abbott, FDA, cataracts

Abbott has announced that the Tecnis Symfony Intraocular Lenses for the treatment of cataracts has been approved by the US …

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Valeant’s psoriasis drug “difficult to assess”, according to FDA staff

July 18, 2016
Research and Development, Sales and Marketing FDA, Valeant, psoriasis

Staff at the US Food and Drug Administration have expressed concerns over Valeant’s psoriasis candidate, brodalumab, due to the potential …

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