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All News - Page 65

Investigational lymphoma treatment gets FDA nod
Investigational lymphoma treatment gets FDA nod
Investigational lymphoma treatment gets FDA nod
August 17, 2020
The drug’s indication for marginal zone lymphoma (MZL) may not be approved until February 2021.
FDA clears first oral drug to treat spinal muscular atrophy
FDA clears first oral drug to treat spinal muscular atrophy
FDA clears first oral drug to treat spinal muscular atrophy
August 11, 2020
Evrysdi is only the second drug approved to treat the rare disease.
Novel IV opioid will be available this year
Novel IV opioid will be available this year
Novel IV opioid will be available this year
August 11, 2020
Olinvyk is the first new chemical entity in this IV drug class in decades.
FDA clears first cell-based gene therapy for lymphoma
FDA clears first cell-based gene therapy for lymphoma
FDA clears first cell-based gene therapy for lymphoma
August 4, 2020
The chimeric antigen receptor (CAR) T cell therapy is the first of its kind for mantle cell lymphoma (MCL).
Controversial depression nasal spray snares new indication
Controversial depression nasal spray snares new indication
Controversial depression nasal spray snares new indication
August 4, 2020
Esketamine (Spravato) can now be used to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
FDA clears novel psoriatic arthritis treatment
FDA clears novel psoriatic arthritis treatment
FDA clears novel psoriatic arthritis treatment
July 21, 2020
The drug is the first treatment approved for active psoriatic arthritis that selectively inhibits interleukin (IL)-23.
Express Scripts accused of overcharging millions of dollars
Express Scripts accused of overcharging millions of dollars
Express Scripts accused of overcharging millions of dollars
July 21, 2020
The PBM overcharged for generic drugs, among other offenses, a new lawsuit claims.
Sandoz to supply critical generic injectable meds
Sandoz to supply critical generic injectable meds
Sandoz to supply critical generic injectable meds
July 14, 2020
The pharma maker is partnering with the nonprofit Civica Rx to help reduce shortages in hospitals.
Another pharma maker recalls metformin over NDMA
Another pharma maker recalls metformin over NDMA
Another pharma maker recalls metformin over NDMA
July 13, 2020
Five other manufacturers have recalled the popular diabetes medication due to the presence of a the carcinogenic ingredient.
Popular HIV-1 med successful, particularly in order adults
Popular HIV-1 med successful, particularly in order adults
Popular HIV-1 med successful, particularly in order adults
July 7, 2020
Gilead will present new data on virologic suppression in adults 65 years and older at AIDS 2020: Virtual this week.
FDA clears first-in-class HIV-1 treatment
FDA clears first-in-class HIV-1 treatment
FDA clears first-in-class HIV-1 treatment
July 6, 2020
Drug helps with heavily-treatment experienced (HTE) adults with multidrug-resistant HIV-1 infection.
U.S. government secures remdesivir supply for COVID-19 patients
U.S. government secures remdesivir supply for COVID-19 patients
U.S. government secures remdesivir supply for COVID-19 patients
June 30, 2020
Price of the drug to treat hospitalized patients revealed.
FDA okays novel breast, colorectal cancer treatments
FDA okays novel breast, colorectal cancer treatments
FDA okays novel breast, colorectal cancer treatments
June 30, 2020
Colorectal cancer drug is the first immunotherapy administered as a first-line treatment and without chemotherapy.
Top 3 drugs to watch in second half 2020
Top 3 drugs to watch in second half 2020
Top 3 drugs to watch in second half 2020
June 23, 2020
These are the top 3 drugs recently approved — or soon to be approved by FDA — to watch in 2020.
Pharma maker seeks fast approval of lymphoma treatment
Pharma maker seeks fast approval of lymphoma treatment
Pharma maker seeks fast approval of lymphoma treatment
June 23, 2020
Investigational treatment will target marginal zone lymphoma (MZL) and follicular lymphoma (FL).
FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction
FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction
FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction
June 16, 2020
The agency revoked its emergency use authorization (EUA) for the drug, while warning about a dangerous interaction with remdesivir.
New pediatric HIV med available
New pediatric HIV med available
New pediatric HIV med available
June 15, 2020
The unique formulation is a dispersible tablet for children.
Major Metformin recalls underway
Major Metformin recalls underway
Major Metformin recalls underway
June 8, 2020
Five pharma markers are recalling the diabetes medication due to the presence of a carcinogenic ingredient.
Remdesivir for COVID-19 in short supply
Remdesivir for COVID-19 in short supply
Remdesivir for COVID-19 in short supply
June 8, 2020
HHS says supply could run out by the end of this month.
New antibiotic for hospital-acquired pneumonia available
New antibiotic for hospital-acquired pneumonia available
New antibiotic for hospital-acquired pneumonia available
June 5, 2020
The agency welcomes another option for serious bacterial infections.
Drug’s indication expanded to reduce heart attack, stroke risk
Drug’s indication expanded to reduce heart attack, stroke risk
Drug’s indication expanded to reduce heart attack, stroke risk
June 2, 2020
Brilinta is already approved to prevent atherothrombotic events in ASC.
Two metformin products recalled, more on the way
Two metformin products recalled, more on the way
Two metformin products recalled, more on the way
June 2, 2020
Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.
FDA approves med for severe malaria
FDA approves med for severe malaria
FDA approves med for severe malaria
May 28, 2020
IV artesunate is the only drug available in the U.S. to treat the disease.
Top 3 COVID-19 stories this week
Top 3 COVID-19 stories this week
Top 3 COVID-19 stories this week
May 19, 2020
FDA authorizes first stand-alone, at-home test, plus other top COVID-19 news stories.
FDA clears new antigen, saliva tests for COVID-19
FDA clears new antigen, saliva tests for COVID-19
FDA clears new antigen, saliva tests for COVID-19
May 11, 2020
Antigen tests, a new category, have a major advantage and disadvantage over COVID-19 tests already approved.
FDA: Fraudulent COVID-19 medical products abound
FDA: Fraudulent COVID-19 medical products abound
FDA: Fraudulent COVID-19 medical products abound
May 11, 2020
Numerous PPEs and testing kits also feature unproven coronavirus claims.
New subcutaneous multiple myeloma treatment available
New subcutaneous multiple myeloma treatment available
New subcutaneous multiple myeloma treatment available
May 5, 2020
Formulation could cause fewer administration-related reactions than IV Darzalex.
COVID-19 vaccines could be ready this year, plus other top news
COVID-19 vaccines could be ready this year, plus other top news
COVID-19 vaccines could be ready this year, plus other top news
May 5, 2020
Popular heartburn medication now in shortage due to COVID-19 test.
FDA restricts hydroxychloroquine use, plus other COVID-19 updates
FDA restricts hydroxychloroquine use, plus other COVID-19 updates
FDA restricts hydroxychloroquine use, plus other COVID-19 updates
April 27, 2020
Agency says the anti-malaria drug can cause heart rhythm problems.
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