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monkeypox aug10 The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the JYNNEOS vaccine for use in individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. JYNNEOS, the Modified Vaccinia Ankara or MVA vaccine, was developed by Denmark's Bavarian Nordic.
AstraZeneca (AZN.L, AZN) and Daiichi Sankyo said Friday that the Food and Drug Administration approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in...
Armata Pharmaceuticals, Inc. (ARMP) announced Monday that the U.S. Food and Drug Administration has cleared its Investigational New Drug or IND application for AP-SA02 in prosthetic joint infection or PJI. The clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage...
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Gemini Therapeutics, Inc. (GMTX) and Disc Medicine, Inc., a privately held company focused on serious hematologic diseases, on Wednesday said that they have entered into an all-stock merger deal to create a new public company. In support of the merger, Disc has secured commitments from a syndicate...
monkeypox aug10 The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the JYNNEOS vaccine for use in individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. JYNNEOS, the Modified Vaccinia Ankara or MVA vaccine, was developed by Denmark's Bavarian Nordic.
NeuroOne Medical Technologies Corp. (NMTC) has submitted a special 510(k) to the FDA for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use. Dave Rosa, CEO of NeuroOne, said, "Our employees and contractors worked exceptionally hard to expedite the testing...
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lyonsmagnus aug11

Lyons Magnus LLC has expanded its initial recall of nutritional and beverage products to include additional brands and code dates, the U.S. Food and Drug Administration announced. The products were recalled due to the potential for microbial contamination, including from the organisms Cronobacter sakazakii and Clostridium botulinum.

chocolatemilk aug08

Longmont Colorado -based Royal Crest Dairy is recalling 2% Chocolate Milk citing the potential to be contaminated with undeclared egg, a known allergen, the U.S. Food and Drug Administration said. The recall involves Farmer's 2% Reduced Fat Chocolate Milk Pints with the code date of AUG-22.

thatsit aug08

Los Angeles, California-based That's it Nutrition, LLC is recalling various flavors of select Dark Chocolate Truffles as they may contain trace amounts of undeclared milk proteins, an allergen, the U.S. Food and Drug Administration said. The recall involves 3.5, 5.0, 16.0 ounce stand up pouches and 12-count packages of Dark Chocolate Truffles. The various flavors include Fig, Date, Banana, Raisin

sangterenergy aug03

Miami, Florida -based Distributor RFR, LLC is recalling certain Sangter Energy Supplement 3000 mg citing the presence of undeclared Sildenafil, the U.S. Food and Drug Administration said. The recall involves lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level.

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Results Date Company Name Ticker Event Indication Outcome
Q4 2022 Mirum Pharmaceuticals Inc. MIRM Top-line data readout phase III trial of Maralixibat(MARCH-PFIC) Progressive Familial Intrahepatic Cholestasis in children
Q4 2022 X4 Pharmaceuticals, Inc. XFOR Top-line results from Phase 3 trial of mavorixafor WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome
Q4 2022 Cyclo Therapeutics, Inc. CYTH Interim analysis topline results from pivotal phase III study of Trappsol Cyclo Niemann-Pick disease type C (NPC-1)
Q4 2022 Addex Therapeutics Ltd ADXN Data from phase IIb/III study of Dipraglurant Dyskinesia associated with Parkinson's disease
Q4 2022 Context Therapeutics Inc. CNTX Final data from two phase 0 biomarker pharmacodynamic trials of ONA-XR Breast cancer
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Researchers at UT Southwestern have identified a molecular pathway, which is responsible for the spread of glioblastoma cancer to surrounding tissue in the brain, and also an existing drug that curbed the tumor growth in animal models. The findings, published in Nature Cell Biology, have led to a clinical...
After a week, daily Covid-positive cases in the United States have again crossed the 200,000 mark. With 220,566 new cases reported on Wednesday, the total number of people that have been infected with coronavirus in the country has risen to 92,562,436, as per Johns Hopkins University's latest data.
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On July 13, the FDA will decide whether or not to approve Regeneron Pharmaceuticals Inc.'s (REGN) REGEN-COV, proposed for the treatment of COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
On this day last year, i.e., June 8, 2021, the FDA approved Pfizer Inc.'s (PFE) Prevnar 20 vaccine to prevent pneumonia and invasive disease caused by 20 types of pneumococcal bacteria in adults 18 years of age and older.
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