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FDA

Showing 15 posts of 1444 posts found.

Arzerra

Arzerra approved by US FDA for leukaemia

January 20, 2016
Research and Development, Sales and Marketing Afrezza, CLL, FDA, Genmab, Novartis, chronic lymphocytic leukaemia, ofatumumab, sBLA, supplementary biologics license application

The FDA has signed-off a supplemental Biologics License Application (sBLA), meaning Arzerra is approved for extended treatment of patients who …

News
Eisai logo

FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

News
FDA sign

FDA criticised for safety data flaws

January 18, 2016
Sales and Marketing FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety

The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish …

News
FDA

FDA says no to BioMarin’s Duchenne Muscular Dystrophy drug

January 14, 2016
Medical Communications, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, FDA, Kyndrisa, drisapersen

The FDA has rejected BioMarin’s Duchenne Muscular Dystrophy (DMD) drug Kyndrisa, saying there was not enough evidence that the drug …

News
dr_robert_califf_image_via_duke_university_school_of_medicine

Senate panel approves Dr Robert Califf as FDA commissioner

January 13, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Dr Robert Califf, FDA, FDA commissioner, Senate

A senate panel has approved president Obama’s nominee Dr Robert Califf to lead the FDA by a clear majority, although …

Appointment
FDA sign

FDA review for Sanofi and Regeneron’s biologic arthritis drug

January 8, 2016
Medical Communications, Sales and Marketing FDA, Regeneron, Sanofi, biologics, rheumatoid arthritis, sarilumab

The FDA has accepted for review a Biologics License Application (BLA) from Sanofi and Regeneron for the rheumatoid arthritis treatment …

News
2000px-food_and_drug_administration_logo

FDA approves AstraZeneca’s gout drug Zurampic

December 23, 2015
Sales and Marketing AstraZeneca, FDA, Zurampic, gout, lensinurad

The US FDA has approved AstraZeneca’s Zurampic to treat high levels of uric acid in the blood. The drug is …

News
Actelion building

Actelion ready to launch Uptravi after FDA approval

December 22, 2015
Research and Development, Sales and Marketing Actelion, FDA, Jean-Paul Clozel, Uptravi, pulmonary arterial hypertension, selexipag

Actelion says it is ready to launch Uptravi, its drug for pulmonary arterial hypertension in the US in January, after …

News
Gilenya

EMA adds warning label to Novartis’ MS treatment Gilenya

December 22, 2015
Manufacturing and Production EMA, European Medicines Agency, FDA, Novartis, PML, basal cell carcinoma, fingolimod, gilenya

Drug safety regulators in Europe have said they will add warnings to the label and prescribing information of Gilenya (fingolimod), …

News
Sun Pharma logo

Sun Pharma hit by FDA inspection warning

December 22, 2015
Manufacturing and Production FDA, Sun Pharma, manufacturing, production

Sun Pharma shares fell some 7% early this week after it emerged the Indian company received a warning letter from …

News
Chest x ray

Roche lung cancer drug Alecensa gets rapid US approval

December 14, 2015
Sales and Marketing Alecensa, FDA, Genentech, Roche, accelerated approval, alectinib, lung cancer, non-small cell lung cancer

The US health watchdog has approved Alecensa, a drug for people with certain types of non-small cell lung cancer manufactured …

News
Novolog pen

Novo Nordisk files for new insulin approval

December 10, 2015
Manufacturing and Production, Research and Development, Sales and Marketing FDA, NDA, Novo Nordisk, NovoLog, diabetes, insulin aspart, new drug application

Novo Nordisk has submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA. If successful, the Danish …

News
Logos

New regulatory submissions for AbbVie and Novo Nordisk

December 4, 2015
Medical Communications AbbVie, EMA, FDA, Novo Nordisk, Viekira Pak, insulin aspart

AbbVie and Novo Nordisk have submitted new drug applications to the US FDA and European Medicines Agency (EMA) respectively. The …

News
Empliciti logo

FDA approves BMS and AbbVie’s Empliciti for multiple myeloma

December 1, 2015
Manufacturing and Production, Sales and Marketing AbbVie, BMS, Bristol-Myers Squibb, Empliciti, FDA, elotuzumab, multiple myeloma

The US healthcare regulator has approved Empliciti – a multiple myeloma treatment co-developed by Bristol-Myers Squibb and AbbVie. The FDA …

News
dna

Companies face mixed fortunes in ultra-orphan approvals

November 26, 2015
Medical Communications, Research and Development BioMarin, Duchenne Muscular Dystrophy, FDA, Genzyme, NICE, ultra-orphan drugs

UK regulator NICE has recommended Vimizin, a drug for a very rare genetic disorder, after the manufacturer and NHS England …

Feature
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