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PTC Therapeutics, Inc. (PTCT) announced Wednesday that Evrysdi(risdiplam) was approved in Japan by the Japanese Ministry of Health, Labor and Welfare for the treatment of spinal muscular atrophy (SMA). The approval has been granted based on data from two pivotal studies evaluating Evrysdi in infants...
Amgen (AMGN) announced Wednesday that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig (erenumab) for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related...
oralbloodthinning jun22 The U.S. Food and Drug Administration approved Boehringer Ingelheim Pharmaceuticals, Inc.'s Pradaxa (dabigatran etexilate) oral blood thinning medication for children. Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth. The only other approved blood thinning medication for children is given by injection.
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Teva Pharmaceutical Industries Ltd. (TEVA) said Wednesday that Japan's Ministry of Health, Labour and Welfare has approved the use of AJOVY or fremanezumab injection for the preventive treatment of migraine in adults. AJOVY is a long-acting anti-CGRP subcutaneous injection that is designed for the...
Amgen (AMGN) announced Wednesday that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig (erenumab) for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related...
Corcept Therapeutics Inc. (CORT) said that preliminary results from its phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer suggested that the combination of the therapy is active in patients, but the apparent level of benefit does not justify...
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bealydeckersnaturals jun23

Bea Lydecker's Naturals, Inc. is recalling six Living Free brand dietary supplement products citing undeclared soy lecithin, the U.S. Food and Drug Administration said. According to the agency, the labels declare lecithin but do not declare soy lecithin.

prairiewolfspirits jun23

Oklahoma City, Oklahoma -based Prairie Wolf Spirits, Inc. is recalling certain Prairie Wolf Distillery hand sanitizer packaged in containers that resemble water bottles, the U.S. Food and Drug Administration said. The product poses a risk of ingestion. The recall involves all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers.

cuisinesolutions jun21

Cuisine Solutions is recalling its JUST Egg flavored plant-based "bites" products due to undeclared allergens, the U.S. Food and Drug Administration said. The recall involves a limited number of 2-pouch retail packages that may contain an incorrect sealed pouch containing whole-egg and milk products, known allergens.

smithsmedical jun18

Medical devices supplier Smiths Medical, affiliated to Smiths Group plc, is recalling certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings, the U.S. Food and Drug Administration said. The recall was initiated after the company became aware of specific models and lots of Jelco insulin syringes that may exhibit skewed odd number line graduation markings.

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Results Date Company Name Ticker Event Indication Outcome
Late 2021 Cidara Therapeutics, Inc. CDTX Top-line data from phase III study of Rezafungin (ReSTORE) modified intention-to-treat (mITT) patients with candidemia and/or invasive candidiasis
Late 2021 Satsuma Pharmaceuticals STSA Filing of NDA for STS101 Migraine
Late 2021 Momenta Pharmaceuticals Inc MNTA Top-line data from phase II/III study of Nipocalimab (M281) Warm Autoimmune Hemolytic Anemia (wAIHA)
Late 2021 Biohaven Pharmaceutical Holding Co Ltd. BHVN Topline data from phase III trial of Troriluzole Spinocerebellar Ataxia in adults
Late 2021 Biohaven Pharmaceutical Holding Co Ltd. BHVN Topline results from phase III clinical trial of Verdiperstat(M-STAR) Multiple System Atrophy
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Synthetic lethality provides a new opportunity in oncology drug development. First described by Calvin Bridges in 1922, synthetic lethality arises when deficiencies in a pair of genes occur simultaneously to result in cell death, but if that deficiency exists in only one gene, the cell will survive.
Breast cancer is said to be the second most common cancer in women after skin cancer. As of January 2021, there were over 3.8 million women with a history of breast cancer in the U.S., according to BreastCancer.org. Estrogen receptor-positive (ER-positive) breast cancer accounts for 78% of the breast cancers.
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The White House declared that The Biden administration has already met President Joe Biden's goal of 70 percent of U.S. adults 30 and older covered under at least one shot of anti-corona vaccine. "We got here because the President treated this as a wartime effort; built a whole-of-government response to defeat the pandemic; and mobilized state and local governments, the private and non-profit sec
The White House has announced plans for large celebrations in communities across the United States on Fourth of July to celebrate what it called "independence from the virus." In a symbolic gesture, more than 1,000 people consisting of military and frontline workers will gather on the White House lawn. At a routine White House briefing, COVID-19 Response Coordinator Jeff Zients said the coronavi
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So far this month, only 2 *novel drugs have secured regulatory approval in the U.S. - Johnson & Johnson's Rybrevant and Apellis Pharmaceuticals' Empaveli - compared to 6 during the same period last year. Now, let's take a look at the biotech stocks facing FDA decision in June 2021.
Four novel drugs were approved by the FDA in March taking the tally of new drug approvals in the first quarter of this year to 14. Let's take a look at what's in store for April 2021.
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Shares of Pliant Therapeutics Inc. (PLRX), which touched an all-time low of $19.50 on Oct.2, 2020, have since gained 49%.
Shares of Ayala Pharmaceuticals Inc. (AYLA) are off 65% from their 52-week high of $28.68, recorded in February of this year, and trade around $10.
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