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FDA approves Teva’s Granix and Galderma’s Soolantra

24-12-2014

The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’…

DermatologicalsGaldermaGranixIvermectinPharmaceuticalRare diseasesRegulationSoolantraTeva Pharmaceutcal IndustriesUSA

US health care predictions from Steven Burrill

24-12-2014

US politics will continue to be characterized by partisanship as the Republican majorities in the House…

BiosimilarsBiotechnologyHealthcarePoliticsRegulationUSA

Novo Nordisk’s obesity drug Saxenda approved by FDA

Novo Nordisk’s obesity drug Saxenda approved by FDA

24-12-2014

Continuing its rush of year-end drug approvals, the US Food and Drug Administration late yesterday approved…

MetabolicsNovo NordiskPharmaceuticalRegulationSaxendaUSA

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

23-12-2014

Swiss biotech company Actelion has submitted a New Drug Application to the US Food and Drug Administration…

ActelionCardio-vascularPharmaceuticalRegulationselexipagSwitzerland

NICE opens consultation on Millennium’s Crohn’s drug Entyvio

23-12-2014

In draft guidance issued today, UK health costs watchdog the National Institute for Health and Care Excellence…

BiotechnologyEntyvioGastro-intestinalsMillennium PharmaceuticalsPricingRegulationTakeda PharmaceuticalUK

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

23-12-2014

Eyecare specialist Alcon, the second-largest division of Swiss drug major Novartis, has been granted…

AlconNovartisOphthalmicsPharmaceuticalRegulationTravatanUSA

BioCryst's Rapivab approved by FDA to treat influenza

BioCryst's Rapivab approved by FDA to treat influenza

23-12-2014

USA-based BioCryst Pharmaceuticals has received approval from the US Food and Drug Administration for…

Antibiotics and Infectious diseasesBioCryst PharmaceuticalsperamivirPharmaceuticalRegulationUSA

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

23-12-2014

The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers…

Bristol-Myers SquibbKeytrudaMerck & CoOncologyOpdivoPharmaceuticalRegulationUSA

Ukraine’s new Health Minister outlines priorities at meeting with APRAD

Ukraine’s new Health Minister outlines priorities at meeting with APRAD

22-12-2014

At the instance of Association of Pharmaceutical Research and Development (APRAD), the Ministry of Health…

PharmaceuticalPoliticsPricingRegulationUkraine

AstraZeneca’s Lynparza gains FDA approval

AstraZeneca’s Lynparza gains FDA approval

20-12-2014

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaLynparzaOncologyPharmaceuticalRegulationUSA

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

20-12-2014

The US Food and Drug Administration on Friday confirmed the much anticipated approval of US pharma company…

AbbVieAnti-viralsPharmaceuticalRegulationUSAViekira Pak

FDA approves new antibacterial drug Zerbaxa

20-12-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’Zerbaxa (ceftolozane/tazobactam)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsMerck & CoPharmaceuticalRegulationUSAZerbaxa

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

19-12-2014

Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine…

ADI-PEG 20OncologyPharmaceuticalPolaris GroupRegulation

CSL Behring files BLA for hemophilia B agent

CSL Behring files BLA for hemophilia B agent

18-12-2014

USA-based CSL Behring, a unit of Australia’s CSL Ltd, has submitted a biologics license application…

CSL BehringCSL LimitedHematologyPharmaceuticalRegulationUSA

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

18-12-2014

US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration…

Cardio-vascularPharmaceuticalPozenRegulationUSAYosprala 325/40Yosprala 81/40

European Commission grants marketing authorization to AstraZeneca's Lynparza

European Commission grants marketing authorization to AstraZeneca's Lynparza

18-12-2014

Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission…

AstraZenecaLynparzaOncologyPharmaceuticalRegulation

FDA approves Alcon’s Xtoro to treat swimmer’s ear

FDA approves Alcon’s Xtoro to treat swimmer’s ear

18-12-2014

The US Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used…

Acute otitis externaAlcon LaboratoriesAntibiotics and Infectious diseasesHealthNovartisPharmaceuticalRegulationUSAXtoro

Eisai's Halaven now available in Russia for advanced breast cancer

Eisai's Halaven now available in Russia for advanced breast cancer

18-12-2014

Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia.

EisaiHalavenOncologyPharmaceuticalRegulationRussia

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

17-12-2014

The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

17-12-2014

In final guidance published today, UK health cost watchdog the National Institute for Health and Care…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

Trade groups call for integrated life science strategy ahead of European Commission Work Program

Trade groups call for integrated life science strategy ahead of European Commission Work Program

16-12-2014

European research and generic/biosimilar industry associatins have called for an integrated life science…

Advocacy groupsCompetitivenessEuropePharmaceuticalRegulation

Novartis gains US FDA approval of Signifor for acromegaly

Novartis gains US FDA approval of Signifor for acromegaly

16-12-2014

The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Signifor (pasireotide)…

NovartisPharmaceuticalRare diseasesRegulationSigniforUSA

1 to 25 of 2714 results

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