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All News - Page 62

MacroGenics treatment for HER2-positive breast cancer to be available in March
MacroGenics treatment for HER2-positive breast cancer to be available in March
MacroGenics treatment for HER2-positive breast cancer to be available in March
January 12, 2021
New treatment for metastatic HER2-positive breast cancer is called Margenza.
Drugmakers raising prices in 2021 but at lower rate
Drugmakers raising prices in 2021 but at lower rate
Drugmakers raising prices in 2021 but at lower rate
January 6, 2021
Many pharmaceutical manufacturers are raising prices this year, but at a lower overall rate than in the past couple of years, according to a new analysis.
FDA clears first generic for treatment for severe hypoglycemia
FDA clears first generic for treatment for severe hypoglycemia
FDA clears first generic for treatment for severe hypoglycemia
January 4, 2021
Amphastar Pharmaceuticals’ generic version will offer stiff competition to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar.
Biosimilar to Rituxan expected to hit market in January
Biosimilar to Rituxan expected to hit market in January
Biosimilar to Rituxan expected to hit market in January
December 22, 2020
The biosimilar to Rituxan is expected to erode market share of the mainstay cancer drug for Roche.
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
December 18, 2020
Orgovyx, the first oral drug in its class, may help reduce clinic visits for men with prostate cancer. Fewer visits may be important during the COVID-19 pandemic.
FDA fast-tracks novel MAB neuroblastoma treatment
FDA fast-tracks novel MAB neuroblastoma treatment
FDA fast-tracks novel MAB neuroblastoma treatment
December 15, 2020
The monoclonal antibody medicine treats neuroblastoma in the bone and bone marrow.
Moderna COVID-19 vaccine approval expected soon
Moderna COVID-19 vaccine approval expected soon
Moderna COVID-19 vaccine approval expected soon
December 15, 2020
FDA deemed Moderna’s vaccine candidate “highly effective,” so the agency may grant an emergency use authorization later this week.
Pharma maker expects myeloma drug approval after positive results
Pharma maker expects myeloma drug approval after positive results
Pharma maker expects myeloma drug approval after positive results
December 8, 2020
After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear Xpovio.
FDA okays first combo COVID-19 and flu test
FDA okays first combo COVID-19 and flu test
FDA okays first combo COVID-19 and flu test
December 8, 2020
The test is for patients to use at home, with a prescription, to detect both COVID-19 and influenza A and B.
First prostate cancer imaging drug approved
First prostate cancer imaging drug approved
First prostate cancer imaging drug approved
December 1, 2020
FDA okayed the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
FDA clears treatment for rare obesity diseases
FDA clears treatment for rare obesity diseases
FDA clears treatment for rare obesity diseases
December 1, 2020
The drug is the first FDA-approved therapy for these rare genetic diseases.
Xofluza, flu drug, snags new indication
Xofluza, flu drug, snags new indication
Xofluza, flu drug, snags new indication
November 24, 2020
FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.
 FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test
 FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test
FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test
November 23, 2020
Regeneron's investigational treatment was administered to President Donald Trump in October when he was treated for COVID-19.
Blockbuster Keytruda earns new breast cancer indication
Blockbuster Keytruda earns new breast cancer indication
Blockbuster Keytruda earns new breast cancer indication
November 17, 2020
Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).
FDA grants emergency use for COVID-19 treatment
FDA grants emergency use for COVID-19 treatment
FDA grants emergency use for COVID-19 treatment
November 10, 2020
The investigational monoclonal antibody therapy bamlanivimab treats mild-to-moderate COVID-19 in adult and pediatric patients.
Pfizer COVID-19 vaccine results positive, but questions remain
Pfizer COVID-19 vaccine results positive, but questions remain
Pfizer COVID-19 vaccine results positive, but questions remain
November 10, 2020
While Pfizer and BioNTech’s first interim analysis demonstrates the efficacy of their SARS-CoV-2 vaccine candidate, some questions remain.
Metformin recalls continue
Metformin recalls continue
Metformin recalls continue
November 3, 2020
Recalls of metformin products due to higher levels of the probable carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than allowed continue.
Trump, Fauci spar over U.S. coronavirus response
Trump, Fauci spar over U.S. coronavirus response
Trump, Fauci spar over U.S. coronavirus response
November 3, 2020
Trump jokes about potentially firing NIAID Director Anthony S. Fauci.
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.
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