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The extensive discussion between the FDA’s advisory committee, company representatives and other interested parties could serve as a cautionary tale to developers of future gene therapies. -
Blueprint Medicines, Opiant Pharmaceuticals and Lexicon Pharmaceuticals are all awaiting FDA decisions this week. -
Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic
5/22/2023
BioArctic AB's partner Eisai announced that they have submitted a Marketing Authorisation Application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products Regulatory Agency in Great Britain.
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GeneDx Regains Compliance with Nasdaq Minimum Bid Price Requirement
5/22/2023
GeneDx announced that it had received a letter from The Nasdaq Stock Market LLC stating that, because the Company’s Class A common stock had a closing bid price at or above $1.00 per share for a minimum of ten consecutive business days, the Company had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on the Nasdaq Global Select Market, as set forth in Nasdaq Listing Rule 5450, and that the matter is now closed.
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AlzeCure is Granted European Patent for NeuroRestore ACD856
5/22/2023
AlzeCure Pharma AlzeCure Pharma AB, a pharmaceutical company that develops candidate drugs for CNS diseases, focusing on Alzheimer's disease and pain, announced that the European Patent Office has granted a patent covering the company's candidate drug ACD856, which is developed against Alzheimer's disease and other disorders with cognitive impairment.
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IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors
5/22/2023
IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration has completed its review of the Amgen-sponsored Investigational New Drug application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.
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Laekna announces first IND clearance by U.S. FDA for internally-discovered LAE102
5/21/2023
Laekna, a clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application of LAE102 antibody to initiate clinical development.
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In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks. -
Abbott Unveils Late-Breaking Data Showing the World's First Dual-Chamber Leadless Pacemaker Study Met All Three Primary Endpoints
5/20/2023
Abbott announced late-breaking results from the AVEIR™ dual-chamber i2i™ Investigational Device Exemption study, a large-scale study to assess the world's first dual-chamber leadless pacemaker, showing that the leadless pacemaker met its three prespecified primary endpoints for safety and performance.
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An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety. -
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023. -
EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
5/19/2023
AbbVie announced that the U.S. Food and Drug Administration has approved EPKINLYTM, as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies.
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EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
5/19/2023
Genmab A/S announced that the U.S. Food and Drug Administration has approved EPKINLY™ as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy.
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FDA Roundup: May 19, 2023
5/19/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
5/19/2023
Sobi announced that the European Medicines Agency has accepted and validated a marketing authorisation application for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups.
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A three-judge panel is reviewing the legal challenge to the FDA’s approval of mifepristone. Any action by the court may result in further appeals, and possibly another Supreme Court decision. -
According to the FDA, the majority of therapies prescribed for children were not tested in pediatric populations. The new guidance aims to change that. -
Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process Receives FDA Greenlight
5/18/2023
RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, recently received FDA approval to begin Phase 1 clinical studies for an investigational new drug.
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RLS and Evergreen Theragnostics Launch Partnership for Sale and Distribution of Neuroendocrine Tumor Diagnostic Octevy™ (Kit for Preparation of GA 68 Dotatoc Injection), Pending Fda Approval
5/18/2023
RLS Inc. and Evergreen Theragnostics, Inc. announced a new agreement for RLS to prepare, sell and distribute doses of the drug candidate OCTEVY™ to PET customers across the US, if the product is approved by the Food and Drug Administration.
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Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.