Food and Drug Administration

Selected news for the healthcare topic - Food and Drug Administration, collected since 10/2017. There are 174K items in the archive. This healthcare topic shares news with Pfizer, COVID-19, COVID-19 Vaccine, Coronavirus, Johnson & Johnson and hundreds of others.

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Date Headline (link) Source Relevant Snippet
6/7/2022 Merck to Hold Investor Event to Highlight Oncology Portfolio and Pipeline | Business Wire Business Wire ... and provide updates from its late-stage development programs and diverse earlier-stage oncology pipeline. Merck leaders will also share the company’s progress in oncology since last year’s ASCO, including 12 U.S. Food and Drug Administration approvals—five in earlier stages of cancer—and three pivotal study readouts.“Ten years ago, at ASCO 2012, interim data from a single Phase 1 study of nine patients evaluating MK-3475 ...
6/7/2022 Global Ureteral Stents Market to Surpass US$ 828.4 Million by 2030, Says Coherent Market Insights PR Newswire ... over the forecast period. For instance, on May 2, 2022 , The Department of Urology, University Hospitals (UH) in Cleveland , in collaboration announced that they received 510 k clearance for relief stent from the U.S. Food and Drug Administration (FDA). This FDA clearance can allow the relief stent to be marketed in the U.S. for patients suffering from kidney stones and other issues causing difficulty with drainage of kidney.Request Sample ...
6/7/2022 Halozyme Announces Commercial Launch of TLANDO‚Ñ¢, an Oral Treatment for Testosterone Replacement Therapy PR Newswire ... undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO‚Ñ¢ was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022 ."We are delighted to announce the commercial availability of TLANDO and provide patients with a convenient oral dosing option for testosterone replacement therapy. The launch of TLANDO ...
6/7/2022 Transdermal Drug Delivery System Market - Emerging Trends & Global Future Forecasts PRSync ... Market : In January 2018, Hisamitsu Pharmaceutical (Japan) launched ALLESAGA TAPE in the Japanese market. In July 2018, UCB (Belgium) received the Import Drug License (IDL) for its transdermal rotigotine patch—NEUPRO from the China Food and Drug Administration (CFDA). In August 2018, Luye Pharma (China) signed an agreement with Bayer AG (Switzerland) to acquire the global rights to the Apleek contraceptive transdermal patch.Growth Driving Factors:The growth of this ...
6/7/2022 bluebird bio Announces Posting of Briefing Documents for Upcoming FDA Advisory Committee Meeting Business Wire SOMERVILLE, Mass.--(BUSINESS WIRE)--Jun 7, 2022--bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting to review elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor and betibeglogene autotemcel (beti-cel) for the treatment ...
6/7/2022 OKAMI MEDICAL ANNOUNCES FDA 510(k) CLEARANCE OF THE LOBO-7 and LOBO-9 VASCULAR OCCLUDERS TO ADDRESS A WIDE RANGE OF PERIPHERAL EMBOLIZATION CASES PR Newswire ALISO VIEJO, Calif. , June 7, 2022 /PRNewswire/ -- Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company's LOBO ® Vascular Occlusion System.Okami Medical - LOBO Vascular Occlusion System The LOBO (LOw-profile ...
6/7/2022 Remilk Secures Self-Affirmed GRAS for Non-Animal, Real Dairy Protein PR Newswire Green Light for Remilk to Transform U.S. Dairy CategoryTEL AVIV, Israel , June 7, Remilk , a global leader in the development and production of animal-free dairy, has obtained self-affirmed GRAS (generally recognized as safe) status, in accordance with U.S. Food and Drug Administration requirements, paving the way for non-animal, real-dairy products in the U.S.Continue ReadingRemilk Secures Self-Affirmed GRAS for Non-Animal, Real Dairy ...
6/7/2022 FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis PR Newswire ... and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthoodTARRYTOWN, N.Y. and PARIS , June 7, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when ...
6/7/2022 FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older PR Newswire Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S. GAITHERSBURG, Md. , June 7, Novavax, Inc. (Nasdaq: NVAX ), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases ...
6/6/2022 FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS PR Newswire New Indication for Amgen's Fifth FDA-approved BiosimilarNow Approved to Treat All Available Rituxan ® IndicationsTHOUSAND OAKS, Calif. , June 6, Amgen (NASDAQ: AMGN ) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan ® , in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more ...
6/6/2022 GSK announces US FDA approval of PRIORIX for the prevention of measles, mumps and rubella in individuals 12 months of age and older Business Wire PHILADELPHIA--(BUSINESS WIRE)--Jun 6, 2022--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PRIORIX (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older.PRIORIX is currently licenced in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with ...
6/6/2022 ORGOVYX® (relugolix) Now Available from Onco360 for the Treatment of Adult Patients with Advanced Prostate Cancer Business Wire ... leading independent Specialty Pharmacy, has been selected by Myovant Sciences to be a specialty pharmacy partner for ORGOVYX ® (relugolix), which is a gonadotropin-releasing hormone (GnRH) antagonist that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer.“Onco360 is honored to become a specialty pharmacy provider for ORGOVYX patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “We ...
6/4/2022 Longer-Term Data from CARTITUDE Program Continue to Show Deep and Durable Responses with Ciltacabtagene Autoleucel Across Lines of Therapy in Patients with Multiple Myeloma | Business Wire Business Wire ... in the treatment of multiple myeloma at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Earlier data from the CARTITUDE-1 study supported recent regulatory approvals for CARVYKTI‚Ñ¢ by the U.S. Food and Drug Administration and the European Commission, and ongoing results from the multi-cohort CARTITUDE-2 study are being used to inform future trials of CARVYKTI‚Ñ¢ treatment in multiple patient populations and treatment settings ...
6/4/2022 Sub-analyses of Landmark ZUMA-7 Trial Reinforce Yescarta® CAR T-cell Therapy Superiority Over Standard of Care (SOC) as Initial Treatment for Patients With Relapsed or Refractory Large B-cell Lymphoma (LBCL) | Business Wire Business Wire SANTA MONICA, Calif.- Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two pre-planned, subgroup analyses of the landmark ZUMA-7 trial of Yescarta ® (axicabtagene ciloleucel), which led to the U.S. Food and Drug Administration ’s (FDA) recent expanded approval of Yescarta as initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of ...
6/3/2022 Global Anti-Vascular Endothelial Growth Factor Therapeutics Market (2022 to 2030) - Share, Size, Trends, Industry Analysis Report PR Newswire ... growth. The anti-vascular endothelial development aspect therapeutics industry is growing due to new product releases, FDA approvals, and research developments. For instance, in September 2021 , Byooviz (ranibizumab-nuna) was approved by the US Food and Drug Administration as the first generic drug to Lucentis (ranibizumab injection) for treating a variety of eye diseases and disorders, which include neovascular (wet) age-related macular degeneration (nAMD), a major cause of damage ...
6/3/2022 FDA Infant Formula Update: June 3, 2022 PR Newswire SILVER SPRING, Md. , June 3, Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's recent increased flexibilities .Company (Product Origin): Nestlé ( Mexico )Product(s): Gerber Good Start GentleType of Formula: GeneralEstimated Quantity: About 1.3 million cans (about 2.2 million pounds or nearly 33 million full-size ...
6/3/2022 Global Benzodiazepine Drugs Market Outlook and Opportunity Analysis 2022-2030 with 2021 as the Base year - ResearchAndMarkets.com | Business Wire Business Wire ... drugs market over the forecast period. For instance, in January 2018, Torrent Pharmaceuticals Ltd. acquired Bio-Pharm, Inc., a U.S.-based generic pharmaceuticals and over-the-counter (OTC) Company which also included a U.S. Food and Drug Administration (FDA) registered 75,000 sqft manufacturing facility in the U.S.Key players are engaged in receiving approval for their products from the regulatory authorities. This is expected to drive growth of the market ...
6/3/2022 Bristol Myers Squibb Withdraws Supplemental Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt) for Non-transfusion Dependent (NTD) Beta Thalassemia | Business Wire Business Wire ... withdrawn a supplemental biologics license application (sBLA) for Reblozyl ® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The Company could not appropriately address the U.S. Food and Drug Administration ’s questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial.“While we will not pursue this indication in ...
6/3/2022 Bristol Myers Squibb to Acquire Turning Point Therapeutics, a Leading Precision Oncology Company Business Wire ... tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. Repotrectinib has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration . In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC.Bristol Myers ...
6/3/2022 Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS | Business Wire Business Wire CAMBRIDGE, Mass.--( BUSINESS WIRE )--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is September 29, 2022 ...