FDA
Takeda withdraws its FDA application for a dengue vaccine due to data disagreements with the authority
Source: Takeda Takeda announced on 11 July that it is withdrawing its application for the dengue vaccine candidate, TAK-003, from ...
FDA criticizes Intas and Ipca for manufacturing flaws at three Indian factories
Following a slowdown in FDA inspections in recent years due to the pandemic, inspections are now back in full swing, ...
New lawsuits from Novo Nordisk are filed against synthetic versions of Wegovy and Ozempic
Source – FDA The increasing demand for GLP-1 drugs, which can lead to significant weight loss, has resulted in unauthorized ...
Following a report of an inhaler leak, Cipla recalls six batches of the asthma medication albuterol
Source – Cipla On July 10 2023, Cipla, a pharmaceutical company that recently received a 23-page Form 483 filing from ...
FDA Grants Approval to Epcoritamab– Redefining the Future of DLBCL
In the world of cancer treatment, groundbreaking advancements are constantly being made, offering new hope for patients and their loved ...
FDA rejects Amneal’s Parkinson’s drug, $500M peak sales goal unattainable
Source – Amneal Pharmaceuticals On July 3, 2023, Amneal Pharmaceuticals’ plans to launch its extended-release Parkinson’s disease treatment, IPX203, by ...
FDA Approves Cyclophosphamide Injection NDA for Multiple Cancers
Source – Nevakar Injectables On July 3, 2023 the FDA has approved a new drug application (NDA) for 200-mg/mL vials ...
Eiger Implements Workforce Reduction as FDA Raises Standards for Hepatitis Drug
Source – Eiger BioPharmaceuticals On June 29, 2023 Eiger BioPharmaceuticals announced a reduction in staffing by 25% and a strategic ...
Quaratusugene Ozeplasmid Plasmid Plus Atezolizumab in ES-SCLC Receives FTD from FDA
Source – Genprex On June 28, 2023, Genprex has announced that the FDA has granted fast track designation (FTD) to ...
VCN-01 Plus Chemotherapy Receives FDA Orphan Drug Designation for Early PDAC Treatment
Source – Theriva Biologics On 28June 2023, the FDA has granted Orphan Drug Designation (ODD) to VCN-01 in combination with ...
As a result of production issues, the FDA rejected Eton Pharma’s proposed therapy for methanol poisoning
Source – Eton Pharmaceuticals Eton Pharmaceuticals’ dehydrated alcohol injection did not receive approval from the FDA and instead received a ...
Reata Pharmaceuticals Begins Launching Its First Commercial Product Skyclarys with Approved Supplement
Source – Reata Pharmaceuticals After receiving approval in the spring, Reata Pharmaceuticals has been eagerly awaiting the launch of its ...
Pediatric Growth Hormone Deficiency Long-Acting Once-Weekly Treatment NGENLA by Pfizer Receives FDA Approval
Source – Pfizer On 29 June 2023, Pfizer and OPKO Health jointly announced that the US Food and Drug Administration ...
The FDA expedites the development of GSK’s vaccine for gonorrhea
Source – GSK GSK’s vaccine for gonorrhea has received a fast-track designation from the FDA, signaling its potential to combat ...
UCB has achieved a long-awaited victory as the FDA grants approval for the myasthenia gravis drug Rystiggo
Source – UCB On 27 June 2023, UCB faced regulatory challenges in the United States for the second consecutive year, ...
Regeneron has faced an unexpected rejection from the FDA for its high-dose version of Eylea due to manufacturing challenges
Source – Regeneron Regeneron’s highly anticipated high-dose version of Eylea has suffered an unexpected setback as the FDA rejected its ...
Verona Pharma has recently filed a New Drug Application to FDA for the use of ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease
Source – Verona Pharma On June 27, 2023, Verona Pharma announced the submission of a New Drug Application (NDA) to ...
FDA has outlined its perspective on clinical trials involving psychedelic drugs
The FDA has released its inaugural guidance document regarding clinical trials involving psychedelic drugs, which represent a burgeoning field of ...
FDA’s Peter Marks Overrides Reviewers’ Rejection to Approve Sarepta’s Gene Therapy for Duchenne Muscular Dystrophy
Despite the FDA review teams initially leaning against approving Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, a memo reveals that ...
FDA Grants Approval to Pfizer’s LITFULO (Ritlecitinib) for Severe Alopecia Areata in Adults and Adolescents
Source: Pfizer Pfizer announced on June 23, 2023, that the U.S. Food and Drug Administration (FDA) has granted approval to ...
FDA rejects Aldeyra’s eye cancer treatment, citing a lack of clinical data, shattering hopes
Source – Aldeyra Therapeutics On June 21, 2023, Aldeyra disclosed that they have received a Complete Response Letter from the ...
Intercept Implements Restructuring as Ocaliva’s Hopes for NASH Treatment Suffer Another FDA Rejection
Source – Intercept Ocaliva by Intercept wasn’t the fatty liver disease breakthrough that the company had anticipated it would be, ...
Sarepta Therapeutics Makes History with FDA Approval of Elevidys, the First Gene Therapy for Duchenne Muscular Dystrophy
Source – Sarepta Therapeutics On June 22, 2023, Sarepta Therapeutics made an announcement regarding the accelerated approval granted by the ...
Sarepta’s Breakthrough DMD Gene Treatment, Elevidys, Triumphs FDA Hurdles at $3.2M
The speedy approval of Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has been achieved after several delays and a close ...
Moderna Application For FDA Approval Of Updated Covid-19 Vaccine
Source – Moderna On June 22, 2023, a regulatory application for Moderna’s updated COVID-19 mRNA vaccine (mRNA-1273.815), which contains spike ...
FDA Grants Priority Review for Bluebird Bio’s Sickle Cell Treatment
Source – bluebird bio On June 21, 2023, the US Food and Drug Administration (FDA) accepted the Biologics Licence Application ...
FDA rejects F2G’s innovative antimicrobial
Source – F2G After the FDA declared it was unable to approve its Olorofim candidate, F2G’s quest to break a ...
Novo Nordisk plans to stop compounded versions of Ozempic and Wegovy with fresh litigation
Source – Fierce Pharma Novo allegedly filed separate lawsuits against health spas, clinics, and pharmacies in Florida, New York, Tennessee, ...
Talazoparib Plus Enzalutamide for HRR Gene-Altered mCRPC Receives FDA Approval
Source – FDA On June 20, 2023, the combination of talazoparib (Talzenna) and enzalutamide (Xtandi) has been approved by the ...
Argenx receives FDA approval for the first gMG subcutaneous treatment
Source – Argenx Argenx has claimed an FDA clearance that might increase its market share in the increasingly competitive market ...
