Regulatory Approvals24 Sept 2025
Noul Co., Ltd. has secured FDA registration for its miLab™ Cartridge CER and SafeFix™ CER, essential components of its miLab™ CER cervical cancer diag...
Regulatory Approvals24 Sept 2025
Biogen announced that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for a high dose regimen of nusi...
Regulatory Approvals19 Sept 2025
Innovent Biologics announced that China's NMPA has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor a...
Regulatory Approvals18 Sept 2025
Biocon Biologics Ltd. (BBL) announced that the U.S. FDA has approved Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq), biosimilars of Prolia® an...
Regulatory Approvals09 Sept 2025
Saol Therapeutics announced that the FDA issued a Complete Response Letter (CRL) for their New Drug Application (NDA) of SL1009 (Sodium Dichloroacetat...
Regulatory Approvals04 Sept 2025
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combin...
Regulatory Approvals04 Sept 2025
C4 Therapeutics announced that its partner, Biogen, received FDA IND acceptance for BIIB142, an IRAK4 degrader. BIIB142 is intended for the treatment...
Regulatory Approvals04 Sept 2025
Agios Pharmaceuticals announced a three-month extension to the FDA's Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Ap...
Regulatory Approvals02 Sept 2025
The US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to PROLIA and XGEVA, res...
Regulatory Approvals02 Sept 2025
Professor Sarfaraz K. Niazi secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This...
Regulatory Approvals01 Sept 2025
Abbott announced that its Navitor transcatheter aortic valve implantation (TAVI) system received CE Mark approval in Europe for an expanded indication...
Regulatory Approvals01 Sept 2025
Boehringer Ingelheim announced the approval of HERNEXEOS® (zongertinib) by China's NMPA for treating adult patients with unresectable, locally advance...
Regulatory Approvals29 Aug 2025
Teva Pharmaceuticals announced the FDA approval and US launch of its generic version of Saxenda® (liraglutide injection), the first generic glucagon-l...
Regulatory Approvals29 Aug 2025
Vanda Pharmaceuticals announced that the FDA granted Orphan Drug Designation to VGT-1849B, a selective JAK2 inhibitor for treating polycythemia vera (...
Regulatory Approvals25 Aug 2025
Valneva announced that the FDA has suspended the license for its chikungunya vaccine, IXCHIQ®, due to four new reports of serious adverse events (SAEs...
Regulatory Approvals25 Aug 2025
Avenacy, a specialty pharmaceutical company, announced the launch of its Lidocaine Hydrochloride Injection, USP, in the United States. This is Avenacy...
Regulatory Approvals18 Aug 2025
Echosens and Novo Nordisk are expanding their partnership to increase awareness and early diagnosis of metabolic dysfunction-associated steatohepatiti...
Regulatory Approvals18 Aug 2025
The FDA has granted full approval to Precigen's Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with Recurrent Respiratory Papillom...
Regulatory Approvals18 Aug 2025
AstraZeneca has launched FluMist Home, a first-of-its-kind at-home delivery service for its FLUMIST® (Influenza Vaccine Live, Intranasal) nasal spray ...
Regulatory Approvals18 Aug 2025
Labcorp announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disea...
Regulatory Approvals18 Aug 2025
Novo Nordisk announced that the FDA has approved Wegovy® (semaglutide 2.4 mg) for the treatment of noncirrhotic metabolic dysfunction-associated steat...
Regulatory Approvals15 Aug 2025
Trinity Biotech plc announced that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH...
Regulatory Approvals14 Aug 2025
DeepSight Technology announced FDA 510(k) clearance for its NeedleVue™ LC1 Ultrasound System. This system, along with the company's NeedleVue™ and OnP...
Regulatory Approvals05 Aug 2025
Agios Pharmaceuticals announced that the Saudi Food and Drug Authority (SFDA) has approved PYRUKYND® (mitapivat) for treating adult patients with non-...
Regulatory Approvals05 Aug 2025
Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-251 for treating Duchenne muscular dystrophy (DMD) amenable ...
Regulatory Approvals04 Aug 2025
BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendo...
Regulatory Approvals30 Jul 2025
Sanofi announced that the FDA granted orphan drug designation to SAR446523, a monoclonal antibody targeting GPRC5D, for the treatment of relapsed or r...
Regulatory Approvals30 Jul 2025
AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for a fixed-duration, all-oral combination of VENCLEXTA (venetoclax) and acalab...
Regulatory Approvals29 Jul 2025
Deciphera Pharmaceuticals and Ono Pharmaceutical announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) ...
Regulatory Approvals28 Jul 2025
Shanton Pharma announced that the FDA granted Fast Track designation to its investigational new drug, SAP-001, for treating hyperuricemia in adult gou...
Regulatory Approvals28 Jul 2025
Krystal Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYJUVEK® (beremagene geperpavec-svdt) for treating dystr...
Regulatory Approvals28 Jul 2025
BeOne Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recomme...
Regulatory Approvals23 Jul 2025
Health Canada has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone, or with pomalidomide and dexamethasone, fo...
Regulatory Approvals22 Jul 2025
Protagonist Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class oral peptide for treati...
Regulatory Approvals16 Jul 2025
ProKidney announced FDA confirmation that the accelerated approval pathway for rilparencel, an autologous cellular therapy for chronic kidney disease ...
Regulatory Approvals16 Jul 2025
Shorla Oncology announced that the FDA granted orphan drug designation to SH-110, an oral liquid formulation of a drug to treat glioma, a rare brain c...
Regulatory Approvals15 Jul 2025
Sun Pharma announced the launch of LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. LEQSELVI ...
Regulatory Approvals15 Jul 2025
Caranx Medical announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter aorti...
Regulatory Approvals15 Jul 2025
Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, in combinat...
Regulatory Approvals15 Jul 2025
Vertex Pharmaceuticals announced that its non-opioid pain medication, JOURNAVX™ (suzetrigine), has been recognized as a groundbreaking healthcare tech...
