Biotechnology News

British drug major AstraZeneca Plc (AZN.L, AZN) announced Tuesday that the U.S. Food and Drug Administration has accepted and granted Priority Review to the supplemental New Drug Application or sNDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone. The sNDA is...
Novavax Inc. (NVAX) said Friday that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 caused by the SARS-CoV-2 in adolescents aged...
British drug maker GSK plc (GSK, GSK.L), in its statement on Zantac (ranitidine) litigation and N-nitrosodimethylamine or NDMA, said the U.S. and European regulators have concluded there is no evidence of a causal association between ranitidine therapy and the development of cancer. The company noted...
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Nektar Therapeutics (NKTR) published preclinical data highlighting the effects of NKTR-255, a polymer-conjugated human IL-15, on natural killer cell function and proliferation in multiple myeloma. In the study, NKTR-255 enhanced: antitumor responses of myeloma derived human natural killer cells against...
ANI Pharmaceuticals, Inc. (ANIP) said on Tuesday that it has received approval from the FDA for the Abbreviated New Drug Application for Dexamethasone Tablets USP 1.5mg, 4mg, and 6mg. ANI's Dexamethasone Tablets USP 1.5mg, 4mg and 6mg are the generic version of the Reference Listed Drug (RLD) Decadron. Dexamethasone...
Revive Therapeutics Ltd. issued an update on the phase 3 trial to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19. The company will now amend the study protocol with the proposed new primary efficacy endpoints and submit to the FDA for further discussion and...
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fifthseason aug16

Fifth Season is recalling a limited amount of its branded Crunchy Sesame Salad Kits due to undeclared milk and egg, known allergens, the U.S. Food and Drug Administration said. The recall involves Fifth Season branded Crunchy Sesame Salad Kit with UPC Code: 52070008147 and Best By Date of 16-AUG-2022 and 15-AUG-2022.

pretzelbuns aug15

King's Hawaiian is recalling its Pretzel Slider Buns, Pretzel Hamburger Buns and Pretzel Bites products as they contain one ingredient already recalled by Lyons Magnus, the U.S. Food And Drug Administration said. The Pretzel recall was initiated out of an abundance of caution after one of its supplier Lyons Magnus recently called back various nutritional and beverage products.

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.

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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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AnaptysBio Inc. (ANAB), a clinical-stage biotechnology company developing innovative immunology therapeutics, has a drug candidate targeting hidradenitis suppurativa in its pipeline.
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For many years, cancer cell metabolism has always been a paradox for scientists. The latest work from researchers at Washington University in St. Louis reveals that it might not be such an anomaly after all. Glucose, which is a common sugar in food, is one of the most important nutrients in the body....
The United States has seen an 18 percent decrease in the number of people getting infected with the coronavirus a day over the last two weeks. With 99,543 new cases reported on Monday, the total number of people that have been infected with the coronavirus in the country has risen to 93,029,887, 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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