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FDA Building
Trump considers next FDA commissioner
Trump considers next FDA commissioner
September 10, 2019
Health groups urge Trump to appoint Acting FDA Commissioner Ned Sharpless.
FDA clears Parkinson’s add-on treatment
FDA clears Parkinson’s add-on treatment
FDA clears Parkinson’s add-on treatment
August 30, 2019
The new drug is an add-on to levodopa/carbidopa for Parkinson’s patients experiencing “off” episodes.
FDA issues warning for certain hepatitis C drugs
FDA issues warning for certain hepatitis C drugs
FDA issues warning for certain hepatitis C drugs
August 29, 2019
Use of these meds to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in liver failure in rare cases.
EpiPen
Generic EpiPen for kids may help with shortage
Generic EpiPen for kids may help with shortage
August 27, 2019
Teva’s generic EpiPen Jr. helps alleviate allergy drug shortage.
DEA to propose marijuana research regs
DEA to propose marijuana research regs
DEA to propose marijuana research regs
August 26, 2019
DEA scrambles to add qualified marijuana growers.
New drug targets key genetic driver of cancer
New drug targets key genetic driver of cancer
New drug targets key genetic driver of cancer
August 19, 2019
FDA approved the third oncology drug in the US that targets a key genetic driver of cancer, rather than a specific tumor.
RA drug could help pharma maker stunt Humira losses
RA drug could help pharma maker stunt Humira losses
RA drug could help pharma maker stunt Humira losses
August 19, 2019
Blockbuster drug could be key to Humira’s successor.
GAO: Generic drug approvals too slow
GAO: Generic drug approvals too slow
GAO: Generic drug approvals too slow
August 13, 2019
While FDA’s drug approval time is generally improving, the agency needs to speed up generic drug application reviews, according to a new report.
Novartis defends data on its $2.1 million drug
Novartis defends data on its $2.1 million drug
Novartis defends data on its $2.1 million drug
August 12, 2019
While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.
Prostate cancer drug poised to generate big sales
Prostate cancer drug poised to generate big sales
Prostate cancer drug poised to generate big sales
August 2, 2019
Drug to treat prostate cancer is expected to produce a major windfall for two pharma makers.
Merck’s Keytruda snags another cancer indication
Merck’s Keytruda snags another cancer indication
Merck’s Keytruda snags another cancer indication
August 2, 2019
FDA approved yet another indication for pembrolizumab (Keytruda) to treat patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC).
FDA adds warning to Xeljanz
FDA adds warning to Xeljanz
FDA adds warning to Xeljanz
July 29, 2019
FDA is adding an important new Boxed Warning on the higher-dose version of this drug.
FDA clears first ready-to-use insulin for IV infusion
FDA clears first ready-to-use insulin for IV infusion
FDA clears first ready-to-use insulin for IV infusion
July 22, 2019
FDA approved the first and only ready-to-use insulin for IV infusion in hospitals and acute care settings.
Overactive bladder drug not linked to CV events
Overactive bladder drug not linked to CV events
Overactive bladder drug not linked to CV events
July 17, 2019
Patients with overactive bladder taking this OAB drug did not experience an excess risk of CV events compared with other treatments.
FDA approves first sensor-enabled inhaler
FDA approves first sensor-enabled inhaler
FDA approves first sensor-enabled inhaler
July 17, 2019
Asthma patients may soon treat themselves with first-ever digital maintenance inhaler.
Experts debate drug pricing policies
Experts debate drug pricing policies
Experts debate drug pricing policies
July 15, 2019
While some are concerned that President Trump’s proposed “favored nations” policy would harm pharma makers, one analyst is not as concerned.
Experts debate drug pricing policies
Experts debate drug pricing policies
Experts debate drug pricing policies
July 15, 2019
While some are concerned that President Trump’s proposed “favored nations” policy would harm pharma makers, one analyst is not as concerned.
EpiPen shortage: Pharma maker, retailer offer aid
EpiPen shortage: Pharma maker, retailer offer aid
EpiPen shortage: Pharma maker, retailer offer aid
July 15, 2019
EpiPens have been in short supply, but stakeholders are trying to fill in the access gap.
FDA warns opioid repackers
FDA warns opioid repackers
FDA warns opioid repackers
July 9, 2019
FDA warns opioid repackers for "significant violations."
FDA fast tracks blockbuster diabetes drug for heart failure
FDA fast tracks blockbuster diabetes drug for heart failure
FDA fast tracks blockbuster diabetes drug for heart failure
July 8, 2019
FDA granted Fast Track designation to a popular diabetes drug to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
Are certain anticholinergic meds linked to dementia risk?
Are certain anticholinergic meds linked to dementia risk?
Are certain anticholinergic meds linked to dementia risk?
July 2, 2019
The validity of a new large study linking anticholinergic drugs to the risk of dementia has stirred up controversy.
Cybersecurity glitch wreaks havoc on insulin pumps
Cybersecurity glitch wreaks havoc on insulin pumps
Cybersecurity glitch wreaks havoc on insulin pumps
July 1, 2019
FDA recalls insulin pumps due to cybersecurity miscommunication.
Effects of female libido drug unknown, advocacy group warns
Effects of female libido drug unknown, advocacy group warns
Effects of female libido drug unknown, advocacy group warns
June 24, 2019
A women’s health organization is concerned about the safety and effectiveness of bremelanotide (Vyleesi) after FDA approved it to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.
Top 4 drugs in the pipeline
Top 4 drugs in the pipeline
Top 4 drugs in the pipeline
June 24, 2019
A new report from OptumRx reveals the top 4 drugs in development for the second quarter of 2019.
First IBS pain-relief device hits market
First IBS pain-relief device hits market
First IBS pain-relief device hits market
June 18, 2019
The first FDA-approved device to reduce functional abdominal pain in younger patients with irritable bowel syndrome is now available to medical providers.
Top 6 Cancer Drug Trends
Top 6 Cancer Drug Trends
Top 6 Cancer Drug Trends
June 17, 2019
A record number of new oncology treatments launched in the US last year and spending on cancer drugs soared. Here are the top 6 cancer drug trends revealed in the report.
FDA okays cluster headache drug
FDA okays cluster headache drug
FDA okays cluster headache drug
June 11, 2019
FDA cleared the first-and-only calcitonin gene-related peptide (CGRP) antibody for cluster headaches.
Self-injectable respiratory medication opens doors for patients with severe asthma
Self-injectable respiratory medication opens doors for patients with severe asthma
Self-injectable respiratory medication opens doors for patients with severe asthma
June 10, 2019
The first respiratory biologic to be approved for administration via an autoinjector will be available in the US soon.
FDA clears novel breast cancer drug
FDA clears novel breast cancer drug
FDA clears novel breast cancer drug
June 3, 2019
FDA cleared alpelisib (Piqray), the first PI3K inhibitor to treat breast cancer, to be used in combination with fulvestrant (Faslodex).
Revolutionary smartphone device could offer migraine sufferers hope
Revolutionary smartphone device could offer migraine sufferers hope
Revolutionary smartphone device could offer migraine sufferers hope
June 3, 2019
FDA granted market authorization for a non-invasive, smartphone device that offers respite from migraines.
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