FDA accepts PTC Therapeutics’ NDA for Sepiapterin, aiming for breakthrough in PKU treatment
PTC Therapeutics, Inc. has announced a significant step forward in its mission to combat phenylketonuria (PKU) by receiving FDA acceptance for the New Drug Application ... Read More
Hurricane Helene wreaks havoc! Baxter’s largest facility shuts down, putting U.S. medical supply at risk
In an unexpected and devastating turn of events, Hurricane Helene has forced Baxter International Inc. to shut down its largest manufacturing facility in the United ... Read More
Sun Pharma reveals new clinical data at the 2024 EADV Congress, showing significant improvements in severe skin conditions
Sun Pharmaceutical Industries Limited has made a significant breakthrough in the treatment of severe dermatological conditions, unveiling new clinical efficacy and safety data at the ... Read More
Cassava Sciences fined $40m over misleading Alzheimer’s drug trial results
In a sensational revelation, Cassava Sciences, Inc., a biotechnology company that has been the center of attention for its experimental Alzheimer's drug, is now embroiled ... Read More
Avicenna.AI’s AI tool CINA-CSpine receives FDA clearance for cervical spine fracture detection
Avicenna.AI has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new artificial intelligence (AI) tool, CINA-CSpine, which is specifically designed ... Read More
Johnson & Johnson’s RYBREVANT approved by FDA as second-line option for EGFR-mutated NSCL
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's RYBREVANT (amivantamab-vmjw) in combination with chemotherapy for the treatment of adult patients with ... Read More
Longboard Pharmaceuticals shares see spike as FDA recognizes potential of bexicaserin in Dravet syndrome
Shares of Longboard Pharmaceuticals, Inc. surged on Thursday after the United States Food and Drug Administration (FDA) granted both Rare Pediatric Disease designation and Orphan ... Read More
Theratechnologies faces critical disruption in EGRIFTA SV supply following FDA-induced factory shutdown
Theratechnologies Inc., a leading biopharmaceutical company based in Montreal, has announced a potentially significant disruption in the supply of its body fat reduction medication, EGRIFTA ... Read More
New hope for eczema sufferers as FDA approves Eli Lilly’s EBGLYSS
Eli Lilly and Company (Lilly) has secured approval from the U.S. Food and Drug Administration (FDA) for its new biologic treatment, EBGLYSS (lebrikizumab-lbkz), for moderate-to-severe ... Read More
GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment
GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and Drug Administration (FDA) granting Breakthrough Therapy Designation ... Read More