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Australia and New Zealand resurrect plans for joint Therapeutic Products Agency; Medicines Australia views impact


The governments of Australian and New Zealand have agreed to proceed with a joint scheme for regulation…


Pfizer and Acura’s tamper resistant opioid Oxecta gets US FDA approval


After a significant delay, drugs behemoth Pfizer (NYSE: PFE) and partner Acura Pharmaceuticals (Nasdaq:…

Acura PharmaceuticalsNeurologicalNorth AmericaOxectaPfizerPharmaceuticalRegulationRemoxy

Bristol-Myers Squibb gets EU approval for Nulojix for kidney transplant rejection


The European Commission yesterday granted marketing authorization for US drug major Bristol-Myers Squibb’s…

Bristol-Myers SquibbEuropeImmunologicalsNulojixPharmaceuticalRegulation

New global strategy to help ensure safety and quality of imported products unveiled by US FDA


The US Food and Drug Administration has unveiled a new strategy to meet the challenges posed by rapidly…

GlobalMarkets & MarketingNorth AmericaPharmaceuticalRegulation

EMA and US FDA get first parallel QbD application; FDA beats EMA on cancer drug appros


The European Medicines Agency (EMA) and the US Food and Drug Administration have agreed to accept the…

EuropeNorth AmericaOncologyPfizerPharmaceuticalRegulation

Unanimous FDA advisory support for Regeneron wet-AMD drug Eylea/VEGF Trap-Eye


As was largely expected following positive briefing papers from the US Food and Drug Administration earlier…

BayerBiotechnologyEyleaOphthalmicsPharmaceuticalRegeneronRegulationVEGF Trap-Eye

Generic drugmakers call to make Europe the “medicines manufacturer of the world”


The key message delivered at the annual conference of the European Generic medicines Association (EGA)…

EuropeGenericsMarkets & MarketingRegulation

German biotech calls for fair treatment of orphan drugs


Orphan drugs are a rapidly expanding subsector of the pharmaceuticals industry. Martina Ochel, chief…

BiotechnologyEuropePricingRare diseasesRegulation

ViroPharma's Cinryze cleared for hereditary angioedema in Europe


The European Commission has granted US biotech firm ViroPharma (Nasdaq: VPHM) Centralized Marketing Authorization…

BiotechnologyCinryzeEuropePharmaceuticalRare diseasesRegulationViroPharma

US FDA approves Bristol-Myers Squibb’s Nulojix for kidney transplant patients


In a much anticipated move following a positive 13 to five advisory committee vote (The Pharma Letter…

belataceptBristol-Myers SquibbImmunologicalsNorth AmericaNulojixPharmaceuticalRegulation

Bladder cancer risk of Takeda’s Actos now highlighted by US FDA


The latest bad news for Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502) came last night…

ActosDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

China drug formulation market could reach $150 billion by 2015


It has been well recognized that the drug formulation has been one of the valued-added technologies for…

Asia-PacificGenericsMarkets & MarketingRegulation

New data show young children need higher antibody levels than adults to ensure protection from influenza infections


A long-standing controversy on the use of influenza vaccines in young children might be coming to an…


Dr Reddy’s warned by US FDA over API facility in Mexico


Indian generic drug major Dr Reddy’s Laboratories (NYSE:RDY) revealed yesterday that its wholly-owned…

Dr Reddy's LaboratoriesGenericsNorth AmericaRegulationSouth America

China SFDA approves new production line for NeoStem’s Suzhau Erye


There was good news for USA-based NeoStem (NYSE Amex: NBS) yesterday, as China’s medicines regulator…


Towards updating Israel’s “basket” of health services in 2012


Towards updating Israel’s “basket” of health services in 2010

HealthcarePharmaceuticalRegulationRest of the World

US FDA warns on risk of more serious forms of prostate cancer with 5-ARI drugs


The US Food and Drug Administration has warned that the labeling for drugs used to treat enlarged prostate…

AvodartGlaxoSmithKlineMerck & CoNorth AmericaOncologyPharmaceuticalProscarRegulation

GlaxoSmithKline and Valeant get FDA approval for epilepsy drug Potiga


Following backing from a US Food and Drug Administration advisory panel last summer (The Pharma Letter…

GlaxoSmithKlineNeurologicalNorth AmericaPharmaceuticalPotigaRegulationTrobaltValeant Pharmaceuticals

US FDA working to lessen drug shortage impact


Last year, the number of drug shortages in the USA reached a record high, and medicine scarcities have…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

France suspends sales of Takeda’s Actos on cancer risk concerns


Sales of blockbuster diabetes drug Actos (pioglitazone), from Japan’s leading drugmaker Takeda Pharmaceuticals…

ActosDiabetesEli LillyEuropePharmaceuticalRegulationTakeda Pharmaceuticals

2332 to 2356 of 2454 results

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