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FDA fast tracks investigational leukemia treatment
FDA fast tracks investigational leukemia treatment
FDA fast tracks investigational leukemia treatment
October 27, 2020
The treatment is a combination of ublituximab, its investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon.
Is medicine delivered via gummies the future?
Is medicine delivered via gummies the future?
Is medicine delivered via gummies the future?
October 27, 2020
Medical company secures Investigational New Drug Application from FDA for its gummy medication.
FDA grants full approval for combination leukemia treatment
FDA grants full approval for combination leukemia treatment
FDA grants full approval for combination leukemia treatment
October 19, 2020
Venclexta was previously granted provisional approval by FDA in late 2018.
Pfizer: COVID-19 vaccine likely ready late November
Pfizer: COVID-19 vaccine likely ready late November
Pfizer: COVID-19 vaccine likely ready late November
October 19, 2020
The pharma maker plans to apply for FDA Emergency Use Authorization for the vaccine after the third week of November.
US government, AstraZeneca team up on COVID-19 preventative med
US government, AstraZeneca team up on COVID-19 preventative med
US government, AstraZeneca team up on COVID-19 preventative med
October 13, 2020
The pharma maker aims to make the treatment available to the most vulnerable populations by December.
RA drug indication expanded to other pediatric autoimmune disorders
RA drug indication expanded to other pediatric autoimmune disorders
RA drug indication expanded to other pediatric autoimmune disorders
October 13, 2020
Simponi Aria is now approved to to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
FDA clears first treatment for mesothelioma in 16 years
FDA clears first treatment for mesothelioma in 16 years
FDA clears first treatment for mesothelioma in 16 years
October 6, 2020
The combination therapy of Opdivo plus Yervoy will treat the cancer caused by inhaling asbestos fibers.
Metformin recalls expand
Metformin recalls expand
Metformin recalls expand
October 6, 2020
The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.
Pfizer snags fourth indication for blockbuster Xeljanz
Pfizer snags fourth indication for blockbuster Xeljanz
Pfizer snags fourth indication for blockbuster Xeljanz
September 29, 2020
Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
FDA requires new boxed warning on benzodiazepines
FDA requires new boxed warning on benzodiazepines
FDA requires new boxed warning on benzodiazepines
September 29, 2020
Xanax and Ativan are among the medications impacted by FDA’s new requirements.
Sun Pharma Recalls 1 Lot of Metformin Due to NDMA Levels
Sun Pharma Recalls 1 Lot of Metformin Due to NDMA Levels
Sun Pharma Recalls 1 Lot of Metformin Due to NDMA Levels
September 28, 2020
Sun Pharmaceuticals issued a voluntary recall of 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL.
Top 5 drugs in the pipeline
Top 5 drugs in the pipeline
Top 5 drugs in the pipeline
September 22, 2020
Some of the top medications were approved this summer, while others are awaiting FDA approval.
Major thyroid med recall underway
Major thyroid med recall underway
Major thyroid med recall underway
September 22, 2020
Both recalls are due to sub-potency of drugs that treat hypothyroidism.
Jardiance to get new heart attack prevention indication
Jardiance to get new heart attack prevention indication
Jardiance to get new heart attack prevention indication
September 15, 2020
The top-selling diabetes drug will join semaglutide (Ozempic), which is approved to reduce the risk of major adverse cardiovascular events.
Carcinoma med snags Breakthrough Therapy Designation
Carcinoma med snags Breakthrough Therapy Designation
Carcinoma med snags Breakthrough Therapy Designation
September 14, 2020
The treatment is the first anti-PD-1 antibody from China to receive Breakthrough therapy designation.
Lung cancer's new drug based on precision medicine
Lung cancer's new drug based on precision medicine
Lung cancer's new drug based on precision medicine
September 8, 2020
Pharma makers expect the treatment to be available within a week.
FDA clears oral leukemia drug
FDA clears oral leukemia drug
FDA clears oral leukemia drug
September 8, 2020
The medication boasts a statistically significant improvement in overall survival versus placebo.
FDA expands emergency use authorization for remdesivir to include all hospitalized COVID-19 patients
FDA expands emergency use authorization for remdesivir to include all hospitalized COVID-19 patients
FDA expands emergency use authorization for remdesivir to include all hospitalized COVID-19 patients
August 31, 2020
One study questions the effectiveness of remdesivir past day 10 while others support its expanded use.
U.S. gov’t, Abbot team up to produce millions of rapid COVID-19 tests
U.S. gov’t, Abbot team up to produce millions of rapid COVID-19 tests
U.S. gov’t, Abbot team up to produce millions of rapid COVID-19 tests
August 28, 2020
The pharma maker will initially produce 150 million of the 5-minute tests.
FDA clears 2 therapies for rare conditions
FDA clears 2 therapies for rare conditions
FDA clears 2 therapies for rare conditions
August 18, 2020
Drug for a specific Duchenne muscular dystrophy mutation is only the second drug approved for the mutation.
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.
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