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Gracell Biotechnologies Inc. (GRCL) announced the FDA has cleared the company's Investigational New Drug application and the company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F for the treatment of relapsed/refractory multiple myeloma. The company plans to initiate a Phase...

gsk feb02 The U.S. Food and Drug Administration approved GlaxoSmithKline LLC's Jesduvroq tablets (daprodustat) for anemia caused by chronic kidney disease or CKD for adults who have been receiving dialysis for at least four months. It is the first oral treatment for anemia, i.e., decreased number of red blood cells, in the given indication that has received FDA approval.

Moderna, Inc. (MRNA) announced mRNA-1345 has been granted Breakthrough Therapy Designation by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years or older. The designation was based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy...

Drug major Merck & Co. Inc. (MRK) announced Friday that the U.S. Food and Drug Administration has approved its anti-PD-1 therapy KEYTRUDA as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a 4 centimeters), II, or...

vaccinations jan27 The Food and Drug Administration's independent advisory committee unanimously recommended replacing the current original COVID vaccines used in the U.S. for primary shots with new bivalent omicron shots authorized as boosters, reports said. The committee also considered the proposal for annual COVID vaccination, however, didn't vote on it.

Merck Animal Health, a division of Merck & Co., Inc. (MRK), announced the U.S. Food and Drug Administration's approval of an expanded indication for BRAVECTO Chews for Dogs. . The new indication treats and controls Asian longhorned ticks. Holger Lehmann, vice president, Pharmaceutical Research and...

ecigarette jan25 The U.S. Food and Drug Administration has denied marketing of two Vuse menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Co. citing that they do not meet public health standard. In a stament, the agency said it has issued marketing denial orders or MDOs for Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.

Kura Oncology, Inc. (KURA) announced the clearance by the FDA of the Investigational New Drug application for KO-2806 for the treatment of advanced solid tumors. The company plans to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy...

Seagen Inc. (SGEN) said Thursday that the U.S. Food and Drug Administration has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment...

Synlogic, Inc. (SYBX), a provider of advancing therapeutics based on synthetic biology, announced Thursday that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation for its SYNB1934 for the potential treatment of phenylketonuria or PKU. Synlogic shares were gaining...

Abbott Laboratories (ABT) announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved the company's latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The...

Irish biopharmaceutical company Alkermes plc (ALKS) announced Tuesday that UK regulatory body, the Medicines and Healthcare products Regulatory Agency or MHRA, has granted an Innovation Passport designation to its immunotherapy nemvaleukin alfa (nemvaleukin) to treat mucosal melanoma. nemvaleukin...

Medical technology company Becton, Dickinson and Co. or BD (BDX) and CerTest Biotec announced Monday emergency use authorization or EUA from the U.S. Food and Drug Administration for a molecular polymerase chain reaction or PCR assay for Mpox virus detection. The company noted that the VIASURE Monkeypox...

IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced Monday that the U.S. Food and Drug Administration has completed its safety review of the Investigational New Drug or IND application of first-in-class PARG Development Candidate IDE161. The agency has concluded that...

Pfizer Inc. (PFE) announced Friday that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application or sBLA for its 20-valent pneumococcal conjugate vaccine candidate in infants and Children. The sBLA is for the 20-valent pneumococcal conjugate or...

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