FDA

Showing 15 posts of 1442 posts found.

Sovaldi image

Sovaldi misses estimates but still makes history

October 29, 2014
Research and Development, Sales and Marketing FDA, Gilead, harvoni, hep C, sofosbuvir, sovaldi

The trajectory of Gilead’s new hep C pill Sovaldi has slowed but the drug is still on course to break …

Boehringer image

Boehringer and Roche IPF drugs win FDA approval

October 16, 2014
Research and Development, Sales and Marketing Boehringer, ERS, Esbriet, FDA, IPF, InterMune, Roche, US, lung scarring, lungs, ofev

The FDA has approved both Roche’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of the fatal lung …

The implantable miniature telescope image

Telescope implant for macular degeneration approved

October 15, 2014
Medical Communications, Sales and Marketing FDA, VisionCare Ophthalmic Technologies, macular degeneration, telescope implant

Medical device development firm VisionCare Ophthalmic Technologies has had its implantable miniature telescope for age-related macular degeneration disease approved by …

Eisai image

FDA approves Eisai’s chemo side-effects drug

October 15, 2014
Research and Development, Sales and Marketing Eisai, FDA, Helsinn, akynzeo, chemotherapy, cinv

Eisai and Helsinn Healthcare’s Akynzeo (netupitant/palonosetron) has received FDA approval for the treatment of chemotherapy-induced nausea and vomiting (CINV). CINV …

Pfizer breast cancer pill gets FDA nod

October 14, 2014
Research and Development, Sales and Marketing FDA, Femera, LEE011, Pfizer, bemaciclib, breast cancer, palbociclib

Pfizer’s experimental breast cancer drug palbociclib has been accepted and granted a priority review by the US Food and Drug …

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Hospira recalls drug due to storage hiccup

October 13, 2014
Manufacturing and Production, Sales and Marketing FDA, Hospira, Vancocin, Vancomycin hydrochloride, lilly

Hospira has issued a recall of one lot of its injectable vancomycin hydrochloride in the US due to ‘uncontrolled storage …

Teva image

Teva to ditch R&D in cancer and women’s health

October 6, 2014
Manufacturing and Production, Research and Development, Sales and Marketing Copaxone, FDA, MS, R&D, Teva, cuts, generics

Teva will stop research into oncology and women’s health in order to cut costs and focus more on generics and …

BMS image

BMS therapeutic cancer vaccine given swift FDA appraisal

September 29, 2014
Sales and Marketing BMS, Bristol-Myers Squibb, Cancer, FDA, Vaccine, bristol myers-squibb, keytruda, melanoma, opdivo

Bristol-Myers Squibb has been granted a speedy review for its new cancer immunotherapy drug Opdivo by the FDA for patients …

FDA accepts new schizophrenia drug filing

September 24, 2014
Sales and Marketing FDA, Lundbeck, Otsuka, brexpiprazole, depression, schizophrenia

The FDA is reviewing Otsuka and Lundbeck’s brexpiprazole for the treatment of schizophrenia and as an adjunctive therapy for the …

FDA approves new indication for Xtandi

September 11, 2014
Sales and Marketing Astellas, FDA, Medivation, Xtandi, Zytiga, prostate

The FDA has approved Astellas Pharma and Medivation’s prostate cancer drug Xtandi (enzalutamide) for use in patients who have not …

fda image

Fourth diet pill makes it to US market

September 11, 2014
Manufacturing and Production, Sales and Marketing Contrave, FDA, Orexigen Therapeutics, diet, obesity

Orexigen Therapeutics has gained FDA approval for its new obesity treatment Contrave to help overweight patients reduce their food intake. …

merck image

BMS sues Merck over new melanoma drug

September 8, 2014
Research and Development, Sales and Marketing BMS, FDA, Merck, PD-1 inhibitors, Yervoy, keytruda

Things are getting ugly between Bristol-Myers Squibb and Merck as the former company began legal proceedings against the latter over …

Amgen image

Amgen submits next gen cholesterol drug

August 29, 2014
Sales and Marketing Amgen, FDA, PCSK9, Regeneron, Sanofi, statins

Amgen has put itself in pole position in the race to market the next generation of injectable statins known as …

Biogen image

FDA approves Biogen’s long-acting MS drug

August 18, 2014
Sales and Marketing Avonex, Biogen, FDA, MS, Rebif, plegridy, tecfidera

Biogen Idec has racked up another approval over the weekend after its latest multiple sclerosis treatment Plegridy gained FDA backing. …

InterMune image

InterMune stock jumps on suitor claims

August 14, 2014
Sales and Marketing Boehringer, Esbriet, FDA, GSK, IPF, InterMune

Riding high of the success of its new lung drug Esbriet, InterMune has become the focus of some serious takeover …

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