FDA
MDMA trials get FDA backing for PTSD treatment
November 30, 2016Research and Development FDA, MDMA, PTSD
The FDA have given the go-ahead to Phase 3 clinical trials investigating the efficacy of MDMA (Methylenedioxymethamphetamine) for treating post-traumatic …
Wockhardt UK sterile site hit with FDA warning
November 29, 2016Manufacturing and Production FDA, Wockhardt, Wrexham
Mumbai-based pharmaceutical and biotechnology firm Wockhardt has been hit with more manufacturing woes as the FDA issued a warning letter …
FDA orphan drug designation doubles PhaseRx shares
November 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing FDA, Orphan Drug Designation, PhaseRx
PhaseRx is celebrating as its lead drug candidate PRX-OTC has been orphan drug designation by the US FDA for the …
Sanofi and Novo to face off in diabetes sphere following FDA approvals
November 22, 2016Manufacturing and Production, Sales and Marketing FDA, Novo Nordisk, Sanofi, Soliqua, Xultophy, diabetes
Sanofi and Novo are set to face off in the diabetes market after the FDA approved combination treatments from the …
AstraZeneca allowed to recruit for drug trial again
November 22, 2016Manufacturing and Production, Research and Development AstraZeneca, FDA, clinical trial
AstraZeneca’s clinical trial for head and neck cancer had previously been put on partial hold by the FDA due to …
Experimental Novartis leukaemia and mastocytosis drug gets FDA Priority Review
November 14, 2016Research and Development, Sales and Marketing FDA, Novartis, acute myeloid leukaemia
The US FDA has granted Priority Review status to Novartis’ experimental drug PKC412 (midostaurin) as a treatment for advanced systemic …
FDA clears digital sensor for GSK inhaler
November 8, 2016Manufacturing and Production, Sales and Marketing FDA, GSK, GlaxoSmithKline, Propeller Health, ellipta
The FDA has given 510(k) clearance to a smart inhaler sensor developed by Propeller Health for use with GlaxoSmithKline’s Ellipta …
Teva antihypertensive generic duo gets FDA thumbs up
November 7, 2016Manufacturing and Production, Sales and Marketing Azor, FDA, Teva, Tribenzor
Teva has received the approval from the US Food and Drug Administration (FDA) for its generic hypertension treatments Tribenzor (olmesartan …
FDA issues warning letter after Chinese firm impedes investigation
November 2, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing China, FDA
The US Food and Drugs Administration (FDA) has issued a Chinese firm with a warning letter after claims it intentionally …
FDA rejects Sarilumab due to production facility issues
October 31, 2016Manufacturing and Production, Sales and Marketing FDA, Regeneron, Sanofi, sarilumab
The US Food and Drugs administration has decided to reject the application for Sarilumab, Regeneron and Sanofi’s rheumatoid arthritis treatment, …
Backlash over testosterone replacement drugs builds with FDA warnings
October 26, 2016Research and Development FDA, FDA Warning, low t, prescription testosterone
The backlash against the over-prescription of ‘testosterone boosters’ continues in the US, with the FDA taking action to add clear …
FDA accepts another Opdivo indication for priority review
October 24, 2016Sales and Marketing BMS, Bristol-Myers Squibb, FDA, opdivo
The FDA has accepted a supplemental Biologics License Application (sBLA) for Bristol-Myers Squibb’s Opdivo for treatment of locally advanced unresectable …
FDA advisory committee approves of Allergan’s night-time urination medicine
October 20, 2016Medical Communications Allergan, FDA, Night-time urination, sleep, urination
The FDA’s advisory committee ruled, in a 14-4 vote, that Allergan’s experimental nocturnal urination medication, SER120, in favour of the …
Eli Lilly gains accelerated approval from FDA for soft tissue sarcoma drug
October 20, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Eli Lilly, FDA, US, soft tissue sarcoma
Eli Lilly received the positive news that their drug, Lartruvo, has been granted accelerated approval for use in conjunction with …
Roche’s immunotherapy cancer drug given FDA approval
October 19, 2016Research and Development Cancer, FDA, Genentech, Roche, immunotherapy, lung cancer
Coming off the back of earlier positive news this month, Roche has revealed that their drug, Tecentriq, has been given …
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