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Showing 15 posts of 1444 posts found.

samsung

FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant

January 22, 2019
Manufacturing and Production, Sales and Marketing FDA, Herceptin, Samsung Bioepis, biosimilar, pharma

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), …

News
16792957331_d9572dbdf4_z

US regulator to recruit 50 new gene and cell therapy clinical reviewers

January 16, 2019
Research and Development FDA, cell therapy, gene therapy, regulation

FDA Commissioner Scott Gottlieb has said that the agency hopes to recruit 50 additional clinical reviewers for the group that …

News
5204602349_c87b204860_z

FDA halts allergy drug approval process due to government shutdown

January 15, 2019
Research and Development Aimmune, FDA, Trump, governmetn, shutdown

California-based pharma firm, Aimunne Therapeutics has been notified that due to the government shutdown, the US Food and Drug Administration …

News
16792957331_d9572dbdf4_z

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 …

News

FDA rejects Mallinckrodt’s abuse-deterrent version of opioid painkiller Roxicodone

December 12, 2018
Research and Development, Sales and Marketing FDA, Mallinckrodt, Roxicodone, opioid crisis, opioids, pharma

Mallinckrodt has hit a snag in its quest to bring an abuse-deterrent version of Roxicodone (oxycodone hydrochloride) to market in …

News
fda2outsideweb

FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics

December 11, 2018
Manufacturing and Production, Sales and Marketing FDA, Novartis, Pear Therapeutics, app, opioid crisis, opioid epidemic, opioids, pharma, reSET-o

A digital therapeutic launched by Pear Therapeutics and Novartis’ generics and biosimilars division Sandoz has become the first FDA-approved app …

News

Astellas’ Xospata becomes US-approved drug for FLT3-mutated acute myeloid leukaemia

November 29, 2018
Sales and Marketing Astellas, FDA, US, Xospata, acute myeloid leukamia

Astellas has revealed that Xospata (gilteritinib) has been awarded FDA approval as a treatment for relapsed or refractory acute myeloid …

News

FDA approves first Rituxan biosimilar courtesy of Teva and Celltrion

November 29, 2018
Sales and Marketing FDA, Genentech, Rituxan, Roche, Teva, Truxima, biosimilars, celltrion

The FDA has announced the first US approval of a biosimilar version of Genentech’s Rituxan (rituximab), awarding marketing approval to …

News
fda2outsideweb

FDA approves first oral TRK inhibitor with Loxo Oncology’s Vitrakvi

November 27, 2018
Manufacturing and Production, Sales and Marketing Cancer, FDA, Loxo Oncology, Vitrakvi, oncology, pharma

The FDA has announced the approval of the United States’ first-ever oral tyrosine kinase (TRK) inhibitor, Loxo Oncology’s Vitrakvi (larotrectinib), …

News

Pfizer’s Daurismo becomes first of its kind to secure FDA approval in acute myeloid leukaemia

November 22, 2018
Research and Development, Sales and Marketing AML, Daurismo, FDA, Pfizer, US, leukaemia

Pfizer has revealed that the FDA has chosen to approve its Daurismo (glasdegib) for the treatment of newly-diagnosed acute myeloid …

News

FDA approves first ever therapy for ultra rare primary haemophagocytic lymphohistiocytosis

November 21, 2018
Research and Development, Sales and Marketing FDA, Novimmune, pharma, sobi

The partnership of Sobi and Novimmune has revealed that their interferon gamma (IFNγ) blocking antibody Gamifant (emapalumab-lzsg) has received approval …

News

Novartis’ Promacta cleared by FDA for first-line use in severe aplastic anaemia

November 19, 2018
Sales and Marketing FDA, Novartis, Promacta, Revolade, US, aplastic anaemia, pharma

Novartis has secured expanded approval from the FDA for Promacta (eltrombopag), allowing it to now be used in combination with …

News
msd

MSD’s Keytruda chalks up FDA approval in liver cancer

November 12, 2018
Sales and Marketing Cancer, FDA, US, hepatocellular carcinoma, keytruda, pharma

MSD’s blockbuster immunotherapy Keytruda has secured another FDA approval, this time for the treatment of hepatocellular carcinoma (HCC) in patients …

News
5204602349_c87b204860_z

FDA commissioner Scott Gottlieb says that more rigorous approval process would be unique to opioids

November 12, 2018
Sales and Marketing FDA, Gottlieb, opioid crisis, opioids

Food and Drug Administration (FDA) commissioner Scott Gottlieb has said that if a more rigorous approval process is introduced for …

News

FDA approves BMS’ multiple myeloma combo after it doubles progression-free survival

November 7, 2018
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, Cancer, Empliciti, FDA, US, multiple myeloma, pharma

The FDA has seen fit to approve Bristol-Myers Squibb’s Empliciti (elotuzumab) intravenous injection in combination with pomalidomide and dexamethasone for …

News
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