approval
Combination first-in-line treatment approved for patients with non-small cell lung cancer
January 23, 2025Research and Development J&J Innovative Medicine, Oncology, approval, non-small cell lung cancer
Johnson & Johnson Innovative Medicine have announced that the European Commission (EC) has approved a marketing authorisation for the combination …
The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
August 29, 2024Research and Development AbbVie, Crohns, Gastrointestinal tract, Immunology, NICE, approval, ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England or Wales with moderately or …
FDA approves Takeda’s first-line treatment option for non-small cell lung cancer
May 26, 2020Manufacturing 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 …
FDA expands indication for Eylea to cover all stages of diabetic retinopathy
May 14, 2019Manufacturing 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 …
FDA approves record breaking 971 generic drugs in 2018
January 10, 2019Manufacturing 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 …
FDA advisory panel approves AcelRx’s opioid pain drug Dsuvia
October 15, 2018Sales 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) …
US FDA approves HPV vaccine for men and women aged 27-45
October 8, 2018Sales 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 …
Teva shares soar after migraine treatment Ajovy approval
September 17, 2018Sales 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 …
Protesters in Manchester call on NICE to approve Biogen’s $750,000 drug Spinraza
September 11, 2018Business 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 …
FDA approves Bristol Myers Squibb’s Opdivo in small-cell lung cancer
August 20, 2018Sales 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 …
Chinese regulators approve Roche’s Alecensa in regulatory shift
August 20, 2018Sales 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 …
Rare lung cancer drug approved in Scotland
August 14, 2018Manufacturing 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 …
EU Commission grants market authorisation for Sandoz’ Humira biosimilar
July 30, 2018Sales 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 …
First new treatment for reccurent malaria approved in over 60 years
July 23, 2018Manufacturing 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 …
FDA approves Agios’ oral leukaemia treatment Tibsovo
July 23, 2018Sales 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 …
