Allecra Therapeutics, a biopharma company developing novel therapies to combat antibiotic resistance, has received FDA approval for its treatment tackling ‘complicated’ urinary tract infections (UTIs).
QBiotics’ lead intratumoural oncology asset, tigilanol tiglate, has been awarded Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) by the United States Food and Drug Administration (FDA).
The US FDA has granted fast track designation to CAN-3110, a viral immunotherapy candidate from Candel Therapeutics to treat patients with recurrent high-grade glioma (HGG) and improve overall survival.
AstraZeneca and Ionis have received FDA approval for Waiuna, their treatment for polyneuropathy in life-threatening disease transthyretin-mediated amyloidosis (ATTR).
The FDA has delayed its decision on whether to approve Bristol Myers Squibb and 2seventy bio’s CAR-T cell therapy, as it plans to seek further advice from experts.
Quest Diagnostics, a provider of diagnostic information services, has announced that its AAVrh74 ELISA assay (CDx) has been granted breakthrough device designation from the U.S. Food and Drug Administration (FDA).
Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.
Genprex has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).
Terumo Blood and Cell Technologies have announced US Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System.
Amgen has announced that the US Food and Drug administration (FDA) has converted the accelerated approval for its blood cancer treatment Blincyto to a full approval.
Locate Bio, a UK-based orthobiologics company, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for LDGraft.
Lumen Bioscience has announced that the US Food and Drug Administration (FDA) has granted fast track designation for LMN-201, its biologic drug to treat and prevent C. difficile infection (CDI).
SiSaf has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (PRDD) by the US Food and Drug Administration (FDA) for its osteopetrosis treatment, SIS-101-ADO.
Memo Therapeutics, a biotech company developing therapeutic antibodies, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to AntiBKV.
Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharma’s developing treatments for Alzheimer’s disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid...
The US regulator has granted emergency authorization for Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant.
CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimer’s disease pathologies.
Anti-competitive actions by companies hamper uptake of biosimilars, the US FDA suggests, and announces a series of actions that will be taken against them.
Shortly after EMA’s approval, the US FDA follows with a positive nod for Ervebo, the first vaccine to receive approval for the prevention of Ebola virus disease.
Clover Biopharmaceuticals will adopt GE Healthcare’s centrally automated FlexFactory platform at its facility in Zhejiang, China where it plans to make a biosimilar to Amgen’s Enbrel.
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.
Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.
The US FDA has finalised guidance supporting new technologies which look to modernise pharmaceutical manufacturing, such as 3D printing and continuous processing.
US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab).
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
Portola Pharmaceuticals Inc has hired Lonza to make AndexXa (andexanet alfa), the candidate anticoagulation antidote it resubmitted for US FDA review last month.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.