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approval

Showing 15 posts of 38 posts found.

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FDA approves Takeda’s first-line treatment option for non-small cell lung cancer

May 26, 2020
Manufacturing and Production FDA, Takeda, approval

The FDA has approved Takeda’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer …

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ipos0_l

FDA expands indication for Eylea to cover all stages of diabetic retinopathy

May 14, 2019
Manufacturing and Production Bayer, Eylea, FDA, Regeneron, approval, pharma

The FDA has expanded the indication for Regeneron’s Eylea (aflibercept) to include all stages of diabetic retinopathy. Regeneron chief scientific …

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FDA approves record breaking 971 generic drugs in 2018

January 10, 2019
Manufacturing and Production FDA, approval, generic drugs, generics, regulation

The FDA approved a record 971 generic drugs in the 2018 fiscal year, giving the go-ahead to 110 generics in …

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FDA advisory panel approves AcelRx’s opioid pain drug Dsuvia

October 15, 2018
Sales and Marketing FDA, approval, comittee, opioids

An FDA advisory panel voted 10 to 3 to recommend the approval of AcelRx Pharmaceuticals’ opioid pain drug Dsuvia (sufentanil) …

News

US FDA approves HPV vaccine for men and women aged 27-45

October 8, 2018
Sales and Marketing CDC, Cancer, FDA, HPV, approval, infectious diseases, vaccines

The US Food and Drug Administration have approved the use of HPV vaccine Gardasil 9 for both men and woman …

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teva_copy

Teva shares soar after migraine treatment Ajovy approval

September 17, 2018
Sales and Marketing FDA, Teva, US, ajovy, approval, israel

Shares in the Israeli pharma firm Teva soared on Sunday after the announcement that the US Food and Drug Administration …

News

Protesters in Manchester call on NICE to approve Biogen’s $750,000 drug Spinraza

September 11, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NICE, Spinraza, approval, protest, sma

Protesters in Manchester have called on the National Institute of Health and Care Excellence (NICE), to overturn their rejection of …

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Image Credit: Bristol-Myers Squibb

FDA approves Bristol Myers Squibb’s Opdivo in small-cell lung cancer

August 20, 2018
Sales and Marketing Bristol-Myers Squibb, FDA, approval, bristol myers squibb, lung cancer, opdivo

The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), as the first …

News

Chinese regulators approve Roche’s Alecensa in regulatory shift

August 20, 2018
Sales and Marketing Cancer, China, Roche, approval, lung cancer

China’s National Drug Administration has granted rapid approval for Roche’s lung cancer treatment Alecensa (alectinib). Chinese regulators have in the …

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Rare lung cancer drug approved in Scotland

August 14, 2018
Manufacturing and Production Cancer, SMC, Scotland, Scottish Medicines Consortium, approval, lung cancer

The Scottish Medicines Consortium has approved Roche’s cancer drug alectinib for the treatment of patients with untreated advanced non-small-cell lung …

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Medicines in an automated pharmacy

EU Commission grants market authorisation for Sandoz’ Humira biosimilar

July 30, 2018
Sales and Marketing FDA, Sandoz, approval, biosimilar, european commision

The European Commission has granted marketing authorisation to Sandoz’ biosimilar Hyrimoz for use in all indications, including rheumatoid arthritis, plaque …

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mosquito-1016254_1280

First new treatment for reccurent malaria approved in over 60 years

July 23, 2018
Manufacturing and Production FDA, GSK, approval, malaria, p.vivax

The FDA has approved GSK’s Krintafel for the treatment of a recurring form of malaria in patients aged 16 and …

News

FDA approves Agios’ oral leukaemia treatment Tibsovo

July 23, 2018
Sales and Marketing FDA, agios, approval, pharmaceuticals, tibsovo

The oral leukaemia treatment Tibsovo (ivosidenib) produced by Massachusetts-based Agios Pharmaceuticals has been approved for treatment of adult patients with …

News

AbbVie and Janssen announce failure of cancer drug Imbruvica in Phase 3 trial

July 12, 2018
Research and Development AbbVie, Cancer, FDA, Janssen, approval

AbbVie and Janssen have announced that Imbruvica (ibrutinib) failed to achieve the primary endpoint in a late-stage study assessing its …

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Insider interview: NICE discusses its planned ‘fast-track’ appraisal process

December 19, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NHS, NICE, UK, approval

Jenniffer Prescott, associate director of planning, operations and topic selection, answers questions on NICE’s recent plans for a ‘fast-track’ appraisal …

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