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Showing 15 posts of 1445 posts found.

kardia_band

ECG Kardia Band becomes first-ever FDA-approved medical device accessory for Apple Watch

November 30, 2017
Sales and Marketing Electrocardiogram, FDA, Kardia Band, apple watch, pharma

The FDA has announced its approval of AliveCor’s Kardia Band, an electrocardiogram for use with the Apple Watch, marking the …

News
scott_gottlieb

FDA unveils guidelines to help generic medical device versions reach the market

November 28, 2017
Research and Development, Sales and Marketing FDA, Mylan, Scott Gottlieb, auto injector, auto-injector, epipen, pharma

The scandal surrounding Mylan’s price-hiking of its flagship EpiPen epinephrine auto-injector was the news of last summer, continuing to grab …

News
shutterstock_138095450

Proposed cuts to National Institutes of Health could delay up to 90% of US drug approvals

November 27, 2017
Research and Development, Sales and Marketing Donald Trump, FDA, NIH, National Institutes of Health, Trump, pharma

President Donald Trump’s budget proposes to cut funding to the National Institutes of Health by $7.2 billion or 21%. Researchers …

News
shutterstock_274590824

Ex-Pharmacy Compliance Director pleads guilty to introducing illegal drugs into the market

November 24, 2017
Medical Communications Department of Justice, FDA, pharma

Caprice Bearden, a 63-year old ex-Director of Compliance for an Indiana-based Pharmakon, has been found guilty of introducing adulterated drugs …

News
gsk_boronia_australia

FDA approves first-ever two-drug HIV regimen, GSK’s Juluca

November 22, 2017
Research and Development, Sales and Marketing AIDS, FDA, GSK, Gilead, GlaxoSmithKilne, HIV, Juluca, ViiV Healthcare, pharma

GlaxoSmithKline has announced that the FDA has awarded US marketing authorisation to the first two-drug regimen in the treatment of …

News

GSK gets EU go-ahead for triple therapy inhaler in COPD

November 16, 2017
Sales and Marketing COPD, FDA, GSK, Trelegy Ellipta, pharma

The EMA has awarded EU marketing authorisation to GlaxoSmithKline and Innovia’s single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for …

News
roche_dark_0

FDA expands Roche drug indication to approve first-ever treatment for rare blood cancer

November 7, 2017
Manufacturing and Production, Sales and Marketing Cancer, Erdheim-Chester Disease, FDA, Roche, blood cancer, pharma

The FDA has announced the approval of Roche’s Zelboraf (vemurafenib) in the treatment of Erdheim-Chester Disease (ECD), expanding its already …

News
gsk_boronia_australia

GSK’s experimental multiple myeloma scores Breakthrough designation with FDA

November 3, 2017
Medical Communications, Research and Development, Sales and Marketing Cancer, FDA, GSK, GlaxoSmithKline, multiple myeloma, pharma

GlaxoSmithKline is celebrating the FDA’s decision to award its experimental therapy GSK2857916 with Breakthrough Therapy Designation as a monotherapy in …

News

FDA issues warnings in crackdown on baseless cannabis miracle cures

November 2, 2017
Research and Development, Sales and Marketing FDA, cannabidiol, cannabis, pharma

The FDA has issued a warning over cannabis-based therapies which promise the ability to cure cancer, asserting that such treatments …

News

Indivior’s opioid addiction treatment recommended by FDA advisory panel

November 1, 2017
Research and Development, Sales and Marketing FDA, RGP-6000, Trump, US, indivior, opioid crisis, opioids

Another step has been made in the fight back against the ongoing opioid crisis in the US as it emerges …

News

GSK’s shingles vaccine scores US approval

October 23, 2017
Sales and Marketing FDA, GSK, Shingrix, pharma, shingles

GlaxoSmithKline has announced that its shingles vaccine Shingrix (Zoster Vaccine Recombinant, Adjuvanted) has been awarded FDA approval for the prevention …

News
janssen_latest_logo_on_sign

FDA expands Janssen’s Stelara to cover adolescent psoriasis patients

October 16, 2017
Sales and Marketing FDA, Janssen, Stelara, pharma, psoriasis

Janssen has announced that the FDA has approved an expanded indication for its psoriasis therapy Stelara (ustekinumab) for the treatment …

News
fda2outsideweb

Aerie’s glaucoma drug gets strong preliminary FDA opinion

October 12, 2017
Sales and Marketing Aerie, Aerie Pharmaceutical, FDA, Glaucoma, Rhopressa, pharma

In a preliminary review of the drug, the FDA has judged that Aerie Pharmaceutical’s experimental glaucoma treatment Rhopressa (netarsudil) effectively …

News
sleeping_man

Battery implant approved to treat sleep apnea

October 9, 2017
Sales and Marketing FDA, biotech, drugs, pharma, pharmaceutical

The FDA has announced the approval of a new form of treatment for central sleep apnea, in the form of …

News

FDA to expedite complex generic approvals to lower drug prices through competition

October 3, 2017
Manufacturing and Production, Sales and Marketing Donald Trump, Drug pricing, FDA, generics, pharma, pharmaceutical

In the midst of ongoing discussions over drug pricing, the FDA has announced plans to facilitate accelerated access to generic …

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