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All News - Page 66

Asthma drug can now be self-administered via pen
Asthma drug can now be self-administered via pen
Asthma drug can now be self-administered via pen
October 8, 2019
Drug is the only respiratory therapy that can be given at home every 8 weeks.
HIV test
Gilead snags approval for second HIV-1 prevention drug
Gilead snags approval for second HIV-1 prevention drug
October 7, 2019
New HIV prevention drug not indicated for women.
Drugstore retailers pull Zantac as recalls expand
Drugstore retailers pull Zantac as recalls expand
Drugstore retailers pull Zantac as recalls expand
September 30, 2019
Drugstore retailers pull ranitidine and Zantac products off the shelves due to cancer concerns.
FDA expands Mavyret for certain hepatitis C patients
FDA expands Mavyret for certain hepatitis C patients
FDA expands Mavyret for certain hepatitis C patients
September 30, 2019
Drug is first 8-week treatment approved for this type of HCV.
Pharma exec: New type 2 diabetes treatment competitively priced
Pharma exec: New type 2 diabetes treatment competitively priced
Pharma exec: New type 2 diabetes treatment competitively priced
September 24, 2019
How the first oral GLP-1 oral treatment for type 2 diabetes is unique and how it will be priced compared to other GLP-1 medications.
Overdoses on the rise for this antidiarrheal drug
Overdoses on the rise for this antidiarrheal drug
Overdoses on the rise for this antidiarrheal drug
September 23, 2019
FDA limits packaging for this OTC medication.
Compounding pills
Manufacturer recalls several compounded drugs over sterility issues
Manufacturer recalls several compounded drugs over sterility issues
September 17, 2019
Fentanyl citrate and ephedrine sulfate are among the medications affected.
Pharmacist examining prescription
Cancer-linked impurity found in heartburn drug
Cancer-linked impurity found in heartburn drug
September 16, 2019
FDA is evaluating risks to patients.
erasing cancer
Lung cancer drug receives breakthrough therapy designation
Lung cancer drug receives breakthrough therapy designation
September 10, 2019
Targeted therapy gives new hope to patients with an aggressive form of lung cancer.
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.
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