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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

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

Auspex leaps on positive results from Phase III trial of SD-809 in Huntington's chorea

Auspex leaps on positive results from Phase III trial of SD-809 in Huntington's chorea

17-12-2014

Movement disorder biopharma specialist Auspex Pharmaceuticals announced positive top-line data from its…

Auspex PharmaceuticalsNeurologicalPharmaceuticalResearchSD-809USA

Portola’s andexanet alfa reverses Eliquis anticoagulant effect

Portola’s andexanet alfa reverses Eliquis anticoagulant effect

17-12-2014

A Phase III clinical trial has found that Portola Pharmaceuticals' andexanet alfa reverses the effects…

andexanet alfaBristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalPortola PharmaceuticalsResearchUSA

New guidance provides optimism for securing life sciences patents in USA

New guidance provides optimism for securing life sciences patents in USA

17-12-2014

The US Patent and Trademark Office (USPTO) has released its 2014 Interim Guidance on Patent Subject Matter…

PatentsPharmaceuticalPrometheus LabsUS Patent and Trademark OfficeUSA

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

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

OPKO Health leaps on potential $570 million deal with Pfizer

OPKO Health leaps on potential $570 million deal with Pfizer

15-12-2014

US drugmaker OPKO Health saw its shares leap 13.8% in pre-market trading, when it revealed a licensing…

LicensingOPKO HealthPfizerPharmaceuticalRare diseasesUSA

Immune Pharmaceuticals appoints Daniel Kazado chairman of the board

Immune Pharmaceuticals appoints Daniel Kazado chairman of the board

15-12-2014

US-Israeli company Immune Pharmaceuticals has appointed Daniel Kazado chairman of the board, succeeding…

BoardroomImmune PharmaceuticalsIsraelPharmaceuticalUSA

FDA approves third indication for Lilly’s Cyramza

FDA approves third indication for Lilly’s Cyramza

13-12-2014

The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s…

CyramzaEli LillyOncologyPharmaceuticalRegulationUSA

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

12-12-2014

The US Food and Drug Administration has so far approved 35 novel drugs this year, compared to 27 last…

BlincytoHarvoniPharmaceuticalRegulationUSA

Court tells Actavis it must continue Namenda IR distribution

Court tells Actavis it must continue Namenda IR distribution

12-12-2014

Ireland-headquartered generic drugmaker Actavis confirmed that Judge Robert Sweet of the US District…

ActavisLegalMarkets & MarketingNamendaNeurologicalPharmaceuticalUSA

Janssen commits $30 million to USAID agreement to fight antibiotic-resistant bacteria

Janssen commits $30 million to USAID agreement to fight antibiotic-resistant bacteria

12-12-2014

US health care giant Johnson & Johnson’s subsidiary Janssen has made an agreement with the United States…

Antibiotics and Infectious diseasesJanssenPharmaceuticalResearchUSA

US FDA issues warning on Pfizer’s Geodon

US FDA issues warning on Pfizer’s Geodon

11-12-2014

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under…

GeodonNeurologicalPfizerPharmaceuticalRegulationUSAZiprasidone

Merck presents early data on Keytruda in advanced triple-negative breast cancer

Merck presents early data on Keytruda in advanced triple-negative breast cancer

11-12-2014

Pharma giant Merck & Co says Keytruda (pembrolizumab) has achieved an overall response rate of 18.5%…

KeytrudaMerck & CoOncologyPharmaceuticalResearchUSA

Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

Lundbeck and Otsuka present Phase III results of brexpiprazole in major depressive disorder

Lundbeck and Otsuka present Phase III results of brexpiprazole in major depressive disorder

10-12-2014

Japanese drug maker Otsuka and Danish CNS specialist Lundbeck have announced Phase III study results…

brexpiprazoleLundbeckNeurologicalOtsukaPharmaceuticalResearchUSA

FDA Focus: Life-threatening disease and the benefit-risk of treatment options

FDA Focus: Life-threatening disease and the benefit-risk of treatment options

10-12-2014

In the fifth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

ChemistryFDAPharmaceuticalRegulationUSA

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

09-12-2014

US biotech major Gilead Sciences has announced long-term follow-up results from the registration studies…

Gilead SciencesOncologyPharmaceuticalResearchUSAZydelig

Labeling update of Lundbeck and Otsuka’s Abilify Maintena approved by FDA

08-12-2014

The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for…

Abilify MaintenaLundbeckNeurologicalOtsuka PharmaceuticalPharmaceuticalRegulationUSA

Sources say Merck to buy Cubist in $7 billion deal

Sources say Merck to buy Cubist in $7 billion deal

08-12-2014

Sources close to the matter say pharma giant Merck & Co has entered negotiations with Cubist Pharmaceuticals…

CubicinCubist PharmaceuticalsMerck & CoMergers & AcquisitionsPharmaceuticalUSA

ASH 2014: Merck reports overall response rate of 66% for its Keytruda in Hodgkin's lymphoma

ASH 2014: Merck reports overall response rate of 66% for its Keytruda in Hodgkin's lymphoma

08-12-2014

Keytruda (pembrolizumab), manufactured by pharma giant Merck & Co, has achieved an overall response rate…

KeytrudaMerck & CoOncologyPharmaceuticalResearchUSA

ASH 2014: AbbVie's venetoclax shows promise in Phase II trial

ASH 2014: AbbVie's venetoclax shows promise in Phase II trial

08-12-2014

US drugmaker AbbVie presented data at the American Society of Hematology’s annual meeting, demonstrating…

AbbVieOncologyPharmaceuticalResearchUSA

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