Amphastar Receives FDA Approval for Ganirelix Acetate Injection
Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application ("ANDA") for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is...
How Innovative Technology is Reshaping Patient Centric-Communications and the Integrity of Self-Reported Patient Data
As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many...
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
FDA Action Alert: BioXcel, Alnylam and Merck
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
Deliberate infection trial finds COVID symptoms don’t indicate viral shedding
The world's first "human challenge" trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the difficulty in preventing...
JW Therapeutics Announces IND Approval for the Pivotal Clinical Trial of Carteyva® in Second-line Large B-Cell Lymphoma
JW Therapeutics, an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products...
U.S. FDA Approves CABENUVA for Adolescents
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies...
FDA authorizes second booster of Pfizer/BioNTech COVID shot
U.S. regulators authorized a second booster dose of Pfizer Inc (PFE.N) and BioNTech SE's (22UAy.DE) COVID-19 vaccine for people 50 and older due to concerns about waning immunity in the age group, the drugmakers said on Tuesday. The U.S. Food and Drug Administration...
InnoCare Announces Approval of Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China
InnoCare Pharma announced today that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its TYK2 JH2 allosteric inhibitor ICP-488, which is the Company's third innovative drug...
Google Tests Catching Heart, Eye Issues From Smartphone Sensors
Google announced on Thursday its latest plans for using smartphones to monitor health, saying it would test whether capturing heart sounds and eyeball images could help people identify issues from home. The company, a unit of Alphabet Inc, is investigating whether the...
How Innovative AI and Digital Health Data are Making Strides in Patient-Focused Care
What if AI could use digital health data to correctly identify the early signs of a serious health issue that is extremely hard to diagnose, yet widespread in hospital settings? In one recent example of healthcare innovation, a cutting-edge AI system that analyzes...
Pfizer Notches Breakthrough Status in Race to an RSV Vaccine
Pfizer has announced Thursday that it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its vaccine candidate PF-06928316 (RSVpreF), intended to prevent infections caused by a respiratory syncytial virus (RSV). The respiratory...
With Robust Results, Moderna to Request Vaccine EUA for Kids Under 6
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age. The data showed a “robust neutralizing antibody response” in both cohorts. The doses were...
Takeda’s Parathyroid Hormone Injection Delayed Indefinitely
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara. Natpara is intended to help patients navigate low blood calcium due to hypoparathyroidism. In Sept. 2019, Takeda issued a U.S. recall of all natpara for...
A New Day in Cancer Treatment: FDA Approves BMS’s Opdualag
Bristol Myers Squibb (BMS) achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of patients 12 and older with unresctable or metastatic melanoma. The decision is based on the...
Moderna and Pfizer are seeking FDA approval for second COVID-19 boosters.
Moderna formally requested the FDA grant emergency authorization for a second booster shot of its COVID-19 vaccine for all adults over 18 who have received approved vaccines. Earlier this week, Pfizer and its partner BioNTech also requested authorization for a second...
COVID-19 Update: The Diabetes Connection, WHO Concerned about BA.2
Viral infections can have a broad range of side effects, such as myocarditis, and COVID-19 is no different. There is evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, an autoimmune disease most commonly...
FDA approves Four Cancer Clinical Trials
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment, including Sonnet BioTherapeutics and Adagene. Sonnet BioTherapeutics evolved into a clinical biopharmaceutical...