FDA
FDA rejects Valeant plaque psoriasis lotion over pharmacokinetic concerns
June 19, 2018Manufacturing and Production, Sales and Marketing FDA, Valeant, pharma, psoriasis
Beleaguered pharma firm Valeant has come up against another bump in the road as its plaque psoriasis lotion Duobrii (halobetasol …
Dr Reddy’s just-approved opioid dependence generic blocked over US patent dispute
June 18, 2018Sales and Marketing Dr Reddy's, FDA, Mylan, US, opioid crisis, opioid dependence, opioids, suboxone
Dr Reddy’s Laboratories has taken two steps forward an one step back after its generic version of Suboxone Film (buprenorphine/naloxone) …
FDA knocks back Mylan’s Advair generic for second time
June 14, 2018Sales and Marketing Advair, FDA, GSK, Mylan, pharma
The FDA has rejected Mylan’s generic version of GlaxoSmithKline’s Advair for the second time following its knockback last year, citing …
FDA greenlights Lilly’s Olumiant in rheumatoid arthritis, with major caveats
June 5, 2018Manufacturing and Production, Sales and Marketing Eli Lilly, FDA, Olumiant, pharma
Eli Lilly has announced that its oral JAK inhibitor Olumiant (baricitinib) has received FDA approval for the treatment of moderately-to-severely …
FDA links intragastric balloons to 5 more deaths, bringing total to 12 since 2016
June 5, 2018Manufacturing and Production, Sales and Marketing FDA, gastric balloon, pharma
Five more deaths have been reported to the FDA in patients using intragastric balloon systems, meaning that 12 total deaths …
Kitov’s combo gets FDA approval in osteoarthritis and hypertension
June 1, 2018Medical Communications, Sales and Marketing Consensi, FDA, Kitov, US, hypertension, osteoarthritis, pharma
Israeli biopharmaceutical firm is celebrating the approval in the US of Consensi, a combo of the calcium channel blocker amlodipine …
Pfizer’s Xeljanz becomes first JAK inhibitor approved in US for active ulcerative colitis
May 31, 2018Sales and Marketing FDA, Pfizer, US, Xeljanz, pharma, ulcerative colitis
Pfizer has revealed that its Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has received FDA approval for the treatment of adult …
FDA approval for TherapeuticsMD, one year after initial rejection
May 30, 2018Sales and Marketing FDA, TherapeuticsMD, biotech, drugs, pharma, pharmaceutical
TherapeuticsMD has succeeded in changing the FDA’s mind on its Imvexxy product, after an initial rejection in May of last …
Allergan recalls 170,000 birth control packs in US over pregnancy fears
May 30, 2018Research and Development Allergan, FDA, Taytulla, US, birth control, pharma
Allergan has issued a voluntary recall of its birth control medication in the US marketplace after an error in packaging …
UCB’s Cimzia secures first-of-its-kind FDA approval in plaque psoriasis
May 29, 2018Manufacturing and Production, Sales and Marketing Cimzia, FDA, UCB, US, pharma, psoriasis
The FDA has expanded the label for UCB’s Cimzia (certolizumab pegol) in the US, approving the therapy for the treatment …
FDA cracks down on benzocaine teething products
May 24, 2018Sales and Marketing FDA, benzocaine, pharma, teething products
The FDA has put its foot down on over-the-counter teething products for infants and children which contain benzocaine, a pain …
Sun Pharma drug combo scores FDA approval in advanced castration-resistant prostate cancer
May 23, 2018Research and Development, Sales and Marketing Cancer, Churchill Pharmaceuticals, FDA, Sun Pharma, US, Yonsa, pharma, prostate cancer
Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in …
FDA reprimands suppliers of opioid substitute kratom products
May 23, 2018Research and Development, Sales and Marketing FDA, kratom, opioid crisis, opioids, pharma
The ongoing opioid epidemic in the US has seen the rise of the sale and use of kratom (mitragyna speciose), …
FDA approves AZ’s Lokelma for hyperkalaemia
May 21, 2018Sales and Marketing AstraZeneca, FDA, Lokelma, hyperkalaemia, pharma
The FDA has revealed its decision to approve AstraZeneca’s oral potassium-removing agent Lokelma (sodium zirconium cyclosilicate) for the treatment of …
Top Ten most popular articles on Pharmafile.com this week
May 18, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cancer, FDA, Novartis, Takeda, Trump, brexit, pharma, pharmafile, top ten
The year is flying by – it’s another Friday, and that means another Top Ten run-down.Perhaps the biggest story this …
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