標籤: fda
Novavax疫苗曙光？FDA或批准，長新冠患者盼望
Novavax新冠疫苗一度跪低，皆因審批delay兼有效成疑？好彩FDA鬆口話有彎轉！對mRNA疫苗有保留嘅市民嚟講，呢個消息算係打咗支強心針。究竟Novavax最終能否過關，成為抗疫新選擇呢？
美國FDA暫緩行動，等法庭裁決Wegovy仿製藥爭議
美國FDA暫緩出手，等埋法庭判決先郁學名藥廠翻版Wegovy。藥廠協會告FDA，想繼續翻版，但Zepbound就輸咗官司。究竟邊間藥廠最後可以分到減肥藥呢杯羹？
Replimune股價因FDA優先審查暴漲！
Replimune嘅股票因為FDA優先審核其針對晚期黑色素瘤嘅治療產品RP1而飆升17%。分析師對此消息反應正面，認為此舉大大降低了未來批准嘅風險，為公司未來商業化奠定基礎。
uniQure基因療法獲FDA加速批准！股價飆升100%
uniQure因與美國FDA達成加速審批協議，其基因療法產品AMT-130股價在盤前交易中飆升100%。這項治療針對亨廷頓舞蹈症，標誌著公司在未來藥物上市過程中的重要進展。
Nano-X Imaging 股價飆升30% 獲FDA新批准！
Nano-X Imaging股價因獲得FDA擴展許可而大漲30%，創下八月以來新高。該公司新系統Nanox.ARC可進行胸部掃描，預計將加速推廣。分析師更將目標價上調至12美元，提升市場信心。
![[Subject]: Young Asian female with "Imada Mio-inspired" doll-like aesthetic (精緻洋娃娃臉). She has large round expressive eyes, a small V-line face, and rosy cheeks. Her expression is innocent, energetic, and slightly flirty. [Hair]: Messy morning hair (剛睡醒的凌亂感), long dark brown hair, slightly tousled, natural volume. [Outfit]: Wearing an oversized translucent white button-down shirt (男友風白襯衫), unbuttoned at the top to reveal collarbones, creating a "bottomless" look (下衣失蹤風格). [Style]: Japanese Gravure Photobook style (寫真集風格), Pure & Sexy vibe, bright high-key lighting, soft skin texture, Fujifilm PRO 400H color tone.](https://ssfuture.shop/wp-content/uploads/ai_gen_1764969341-300x167.png)
![In a brightly lit indoor setting, likely a press conference room, two uniformed police officers flank a man in a plain brown t-shirt. The officers, wearing blue shirts with epaulets and badges, have a firm but neutral grip on the man's shoulders, directing him towards the cameras. The man [image uploaded] with short dark hair, is smiling subtly and maintaining eye contact with the lens.
Stretching across the foreground is a white-draped table, upon which a diverse collection of women's underwear is meticulously displayed. There are dozens of pairs in various colors, patterns, and styles, including solid hues of red, blue, pink, and black, as well as leopard print and other designs. Several microphones with news station logos are placed among the undergarments, pointing towards the man and officers.
Behind the table, a throng of journalists and photographers are actively documenting the event. Many are holding professional video cameras with large lenses and attached lights, while others are using DSLR cameras with flash attachments, and some are capturing footage with their smartphones. The room is illuminated by rectangular fluorescent light panels on the ceiling, casting an even glow. The overall atmosphere suggests a formal public presentation, possibly a police press briefing or an arrest announcement.](https://ssfuture.shop/wp-content/uploads/ai_gen_1764968297-300x300.png)
![[Subject]: Young Asian female with "Imada Mio-inspired" doll-like aesthetic (精緻洋娃娃臉). She has large round expressive eyes, a small V-line face, and rosy cheeks. Her expression is innocent, energetic, and slightly flirty. [Hair]: Messy morning hair (剛睡醒的凌亂感), long dark brown hair, slightly tousled, natural volume. [Outfit]: Wearing an oversized translucent white button-down shirt (男友風白襯衫), unbuttoned at the top to reveal collarbones, creating a "bottomless" look (下衣失蹤風格). [Style]: Japanese Gravure Photobook style (寫真集風格), Pure & Sexy vibe, bright high-key lighting, soft skin texture, Fujifilm PRO 400H color tone.](https://ssfuture.shop/wp-content/uploads/ai_gen_1764973286-300x300.png)