SPOTLIGHT -
Blockbuster Keytruda earns new breast cancer indication
Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).
Metformin recalls expand
The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.
Top 5 drugs in the pipeline
Some of the top medications were approved this summer, while others are awaiting FDA approval.
Carcinoma med snags Breakthrough Therapy Designation
The treatment is the first anti-PD-1 antibody from China to receive Breakthrough therapy designation.
U.S. gov’t, Abbot team up to produce millions of rapid COVID-19 tests
The pharma maker will initially produce 150 million of the 5-minute tests.
FDA clears first cell-based gene therapy for lymphoma
The chimeric antigen receptor (CAR) T cell therapy is the first of its kind for mantle cell lymphoma (MCL).
FDA clears novel psoriatic arthritis treatment
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
The PBM overcharged for generic drugs, among other offenses, a new lawsuit claims.
Popular HIV-1 med successful, particularly in order adults
Gilead will present new data on virologic suppression in adults 65 years and older at AIDS 2020: Virtual this week.
FDA okays novel breast, colorectal cancer treatments
Colorectal cancer drug is the first immunotherapy administered as a first-line treatment and without chemotherapy.
Major Metformin recalls underway
Five pharma markers are recalling the diabetes medication due to the presence of a carcinogenic ingredient.
Remdesivir for COVID-19 in short supply
HHS says supply could run out by the end of this month.
New antibiotic for hospital-acquired pneumonia available
The agency welcomes another option for serious bacterial infections.
Drug’s indication expanded to reduce heart attack, stroke risk
Brilinta is already approved to prevent atherothrombotic events in ASC.
Two metformin products recalled, more on the way
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
IV artesunate is the only drug available in the U.S. to treat the disease.
Pharma maker recalls drug over undeclared anti-hypertensive drug
Top 3 COVID-19 stories this week
FDA authorizes first stand-alone, at-home test, plus other top COVID-19 news stories.
FDA clears new antigen, saliva tests for COVID-19
Antigen tests, a new category, have a major advantage and disadvantage over COVID-19 tests already approved.
FDA: Fraudulent COVID-19 medical products abound
Numerous PPEs and testing kits also feature unproven coronavirus claims.
New subcutaneous multiple myeloma treatment available
Formulation could cause fewer administration-related reactions than IV Darzalex.
COVID-19 vaccines could be ready this year, plus other top news
Popular heartburn medication now in shortage due to COVID-19 test.
FDA restricts hydroxychloroquine use, plus other COVID-19 updates
Agency says the anti-malaria drug can cause heart rhythm problems.
FDA warns CBD companies making medical claims
Suppliers claim CBD can help alleviate opioid addiction, cure diseases.
New lung cancer treatment launches
The drug, plus chemotherapy, shows a significant survival benefit.
FDA clears first home COVID-19 test, plus other top news
Hospitals could receive $75 billion in funding to combat coronavirus.
Another RA drug starts testing to treat COVID-19
Olumiant trial joins other RA drug trials, including hydroxychloroquine.
COVID-19 drug price skyrockets, clinical trial begins
An NIH trial on the controversial anti-malaria medication is underway.
Trump, Fauci disagree on the effectiveness of hydroxychloroquine
More COVID-19 patients receive anti-malaria drug despite controversy.
FDA authorizes treatment, rapid test for COVID-19
Agency issues Emergency Use Authorization for hydroxychloroquine sulfate, along with a novel COVID-19 test.
