FDA
Head of opioid advisory panel criticises FDA for complacency in ongoing crisis
January 28, 2019Medical Communications, Sales and Marketing Dsuvia, FDA, opioid crisis, opioids, pharma
The opioid crisis continues to be a top healthcare concern in the US, but the head of the FDA’s Anesthetic …
FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant
January 22, 2019Manufacturing 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), …
US regulator to recruit 50 new gene and cell therapy clinical reviewers
January 16, 2019Research 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 …
FDA halts allergy drug approval process due to government shutdown
January 15, 2019Research 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 …
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 rejects Mallinckrodt’s abuse-deterrent version of opioid painkiller Roxicodone
December 12, 2018Research 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 …
FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics
December 11, 2018Manufacturing 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 …
Astellas’ Xospata becomes US-approved drug for FLT3-mutated acute myeloid leukaemia
November 29, 2018Sales 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 …
FDA approves first Rituxan biosimilar courtesy of Teva and Celltrion
November 29, 2018Sales 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 …
FDA approves first oral TRK inhibitor with Loxo Oncology’s Vitrakvi
November 27, 2018Manufacturing 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), …
Pfizer’s Daurismo becomes first of its kind to secure FDA approval in acute myeloid leukaemia
November 22, 2018Research 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 …
FDA approves first ever therapy for ultra rare primary haemophagocytic lymphohistiocytosis
November 21, 2018Research 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 …
Novartis’ Promacta cleared by FDA for first-line use in severe aplastic anaemia
November 19, 2018Sales 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 …
MSD’s Keytruda chalks up FDA approval in liver cancer
November 12, 2018Sales 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 …
FDA commissioner Scott Gottlieb says that more rigorous approval process would be unique to opioids
November 12, 2018Sales 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 …
Latest content
Five Facts about cardiovascular disease
