📰 The @fda.gov has granted priority review to elinzanetant for the treatment of moderate-to-severe vasomotor symptoms in patients receiving endocrine therapy for the management or prevention of HR+ breast cancer. #bcsm #oncology
Read more ➡️: www.onclive.com/view/fda-gra...
Read more ➡️: www.onclive.com/view/fda-gra...
FDA Grants Priority Review to Elinzanetant for Endocrine Therapy–Associated Vasomotor Symptoms in HR+ Breast Cancer | OncLive
The sNDA for elinzanetant seeks FDA approval for moderate-to-severe vasomotor symptoms in women receiving endocrine therapy for HR-positive breast cancer.
www.onclive.com
September 28, 2026 at 8:11 PM
📰 The @fda.gov has granted priority review to elinzanetant for the treatment of moderate-to-severe vasomotor symptoms in patients receiving endocrine therapy for the management or prevention of HR+ breast cancer. #bcsm #oncology
Read more ➡️: www.onclive.com/view/fda-gra...
Read more ➡️: www.onclive.com/view/fda-gra...
【ARIKAYCEの正式承認申請、FDAが優先審査】
Insmedのアミカシンリポソーム吸入。MAC肺症に対する一部変更承認申請が優先審査になった。PDUFAは2027年1月28日。加速承認から正式承認へ進める申請であり、いま承認が下りた話ではない。
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
stellanews.life/technology/1...
Insmedのアミカシンリポソーム吸入。MAC肺症に対する一部変更承認申請が優先審査になった。PDUFAは2027年1月28日。加速承認から正式承認へ進める申請であり、いま承認が下りた話ではない。
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
stellanews.life/technology/1...
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
米国食品医薬品局（FDA）は、Insmed社の吸入抗菌薬アミカシンリポソーム吸入用懸濁液（ARIKAYCE）について、MAC（Mycobacterium avium complex）肺症を対象とした正式承認（フル承認）を求める一部変更承認申請（sNDA）を優先審査に指定し、審査完了目標日を2027年1月28日に設定した。
stellanews.life
September 28, 2026 at 4:08 AM
【ARIKAYCEの正式承認申請、FDAが優先審査】
Insmedのアミカシンリポソーム吸入。MAC肺症に対する一部変更承認申請が優先審査になった。PDUFAは2027年1月28日。加速承認から正式承認へ進める申請であり、いま承認が下りた話ではない。
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
stellanews.life/technology/1...
Insmedのアミカシンリポソーム吸入。MAC肺症に対する一部変更承認申請が優先審査になった。PDUFAは2027年1月28日。加速承認から正式承認へ進める申請であり、いま承認が下りた話ではない。
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
stellanews.life/technology/1...
FDA has accepted its supplemental New Drug Application (sNDA) for lower doses of Joenja® (leniolisib) to treat children aged 4 years and older...
🚀 Free alerts → https://gunpowderalerts.com/go?utm_source=bluesky&utm_medium=social&utm_campaign=high_priority_filing
#FinTwit #FinancialDisclosure #6K
🚀 Free alerts → https://gunpowderalerts.com/go?utm_source=bluesky&utm_medium=social&utm_campaign=high_priority_filing
#FinTwit #FinancialDisclosure #6K
September 25, 2026 at 8:17 PM
FDA has accepted its supplemental New Drug Application (sNDA) for lower doses of Joenja® (leniolisib) to treat children aged 4 years and older...
🚀 Free alerts → https://gunpowderalerts.com/go?utm_source=bluesky&utm_medium=social&utm_campaign=high_priority_filing
#FinTwit #FinancialDisclosure #6K
🚀 Free alerts → https://gunpowderalerts.com/go?utm_source=bluesky&utm_medium=social&utm_campaign=high_priority_filing
#FinTwit #FinancialDisclosure #6K
🟢 #$PHAR — Regulatory Designation
Priority Review Granted - Joenja Lower-Dose Pediatric sNDA
The FDA granted Priority Review to Pharming's sNDA for lower doses of Joenja (leniolisib) for children aged 4+ weighing 13-27 kg with APDS, alongside acceptance of the …
https://biostock.app/symbols/PHAR
Priority Review Granted - Joenja Lower-Dose Pediatric sNDA
The FDA granted Priority Review to Pharming's sNDA for lower doses of Joenja (leniolisib) for children aged 4+ weighing 13-27 kg with APDS, alongside acceptance of the …
https://biostock.app/symbols/PHAR
September 25, 2026 at 3:21 PM
🟢 #$PHAR — Regulatory Designation
Priority Review Granted - Joenja Lower-Dose Pediatric sNDA
The FDA granted Priority Review to Pharming's sNDA for lower doses of Joenja (leniolisib) for children aged 4+ weighing 13-27 kg with APDS, alongside acceptance of the …
https://biostock.app/symbols/PHAR
Priority Review Granted - Joenja Lower-Dose Pediatric sNDA
The FDA granted Priority Review to Pharming's sNDA for lower doses of Joenja (leniolisib) for children aged 4+ weighing 13-27 kg with APDS, alongside acceptance of the …
https://biostock.app/symbols/PHAR
FDA receives sNDA for selinexor, ruxolitinib in myelofibrosis.
Read more here. sohoinsider.com/news/fda-rec...
Read more here. sohoinsider.com/news/fda-rec...
September 23, 2026 at 7:57 PM
FDA receives sNDA for selinexor, ruxolitinib in myelofibrosis.
Read more here. sohoinsider.com/news/fda-rec...
Read more here. sohoinsider.com/news/fda-rec...
FDA Flashback: ✨August 2026✨ in #BreastCancer
🔹 sNDA filed for gedatolisib in PIK3CA-mutant HR+/HER2– ABC
🔹 Fast track for PARG inhibitor ETX-19477 in BRCAm disease
🔹 2 giredestrant PDUFA dates ahead #bcsm #oncology
Learn more 🔎: www.onclive.com/view/fda-fla...
🔹 sNDA filed for gedatolisib in PIK3CA-mutant HR+/HER2– ABC
🔹 Fast track for PARG inhibitor ETX-19477 in BRCAm disease
🔹 2 giredestrant PDUFA dates ahead #bcsm #oncology
Learn more 🔎: www.onclive.com/view/fda-fla...
FDA Flashback: Breast Cancer Decisions and News From August 2026 | OncLive
Read a refresh of breast cancer FDA news from August 2026, including an sNDA application in PIK3CA-mutant disease and a fast track designation.
www.onclive.com
September 23, 2026 at 3:13 PM
FDA Flashback: ✨August 2026✨ in #BreastCancer
🔹 sNDA filed for gedatolisib in PIK3CA-mutant HR+/HER2– ABC
🔹 Fast track for PARG inhibitor ETX-19477 in BRCAm disease
🔹 2 giredestrant PDUFA dates ahead #bcsm #oncology
Learn more 🔎: www.onclive.com/view/fda-fla...
🔹 sNDA filed for gedatolisib in PIK3CA-mutant HR+/HER2– ABC
🔹 Fast track for PARG inhibitor ETX-19477 in BRCAm disease
🔹 2 giredestrant PDUFA dates ahead #bcsm #oncology
Learn more 🔎: www.onclive.com/view/fda-fla...
The SNDA Would Like a Lil' Tweat
Playing Master Detective Archives: RAIN CODE today with @lati-oni.bsky.social !!
Now live on Twitch
www.twitch.tv/soapxalotl
Playing Master Detective Archives: RAIN CODE today with @lati-oni.bsky.social !!
Now live on Twitch
www.twitch.tv/soapxalotl
September 23, 2026 at 1:02 AM
The SNDA Would Like a Lil' Tweat
Playing Master Detective Archives: RAIN CODE today with @lati-oni.bsky.social !!
Now live on Twitch
www.twitch.tv/soapxalotl
Playing Master Detective Archives: RAIN CODE today with @lati-oni.bsky.social !!
Now live on Twitch
www.twitch.tv/soapxalotl
Small-cap stocks with declining money flow, Mon Sept 21st - #$SNDA #$ADNT #$REW #$YELP #$TUYA #$SMHI #$RU #$PRSU #$NOA #$LAR #$KRP #$FPH #$EE #$CXM #$ACEL - More: crystalequityresearch.com/trade-alerts... - #smallcap
Trade Alerts, Monday September 21, 2026 – Crystal Equity Research
crystalequityresearch.com
September 21, 2026 at 10:05 PM
Celcuity ($CELC) Stock Hub: sNDA Filed for the PIK3CA-Mutant Cohort, First REVTORPYK Shipments Guided for Late Quarter and Two September Fireside Chats
https://merlintrader.com/celc-celcuity-inc/
https://merlintrader.com/celc-celcuity-inc/
Celcuity ($CELC) Stock Hub: REVTORPYK Approval, Launch And Q2 2026 Financials
Celcuity ($CELC) after the July 14, 2026 FDA approval of REVTORPYK: the label, VIKTORIA-1 data, launch timing, the $575M convertible, $754.0M liquidity and the catalysts that decide the next four quarters.
merlintrader.com
September 18, 2026 at 10:38 AM
Celcuity ($CELC) Stock Hub: sNDA Filed for the PIK3CA-Mutant Cohort, First REVTORPYK Shipments Guided for Late Quarter and Two September Fireside Chats
https://merlintrader.com/celc-celcuity-inc/
https://merlintrader.com/celc-celcuity-inc/
Organon、銅子宮内避妊システム「MIUDELLA」の使用期間延長でsNDAがFDA審査受理──6年間使用への申請内容を整理
stellanews.life/medicaldevic... #MIUDELLA #sNDA
stellanews.life/medicaldevic... #MIUDELLA #sNDA
Organon、銅子宮内避妊システム「MIUDELLA」の使用期間延長でsNDAがFDA審査受理──6年間使用への申請内容を整理
Organonは2026年9月14日、Sebela Women's Healthが申請した銅子宮内避妊システム「MIUDELLA」の使用期間を3年から6年に延長する一部変更承認申請（sNDA）について、米国FDAが審査を受理したと発表した。承認可否の判断は2027年第2四半期に見込まれる。
stellanews.life
September 16, 2026 at 10:45 PM
Organon、銅子宮内避妊システム「MIUDELLA」の使用期間延長でsNDAがFDA審査受理──6年間使用への申請内容を整理
stellanews.life/medicaldevic... #MIUDELLA #sNDA
stellanews.life/medicaldevic... #MIUDELLA #sNDA
【銅IUSのMIUDELLA、使用3年から6年へ申請が受理】
Organon。FDAがsNDAの審査を開始した段階で、延長承認そのものではない。
Organon。FDAがsNDAの審査を開始した段階で、延長承認そのものではない。
September 16, 2026 at 10:45 PM
【銅IUSのMIUDELLA、使用3年から6年へ申請が受理】
Organon。FDAがsNDAの審査を開始した段階で、延長承認そのものではない。
Organon。FDAがsNDAの審査を開始した段階で、延長承認そのものではない。
🟢 #$BFRI — Regulatory Approval
FDA Approval - Ameluz PDT for Superficial Basal Cell Carcinoma
FDA approved the sNDA for Ameluz topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for treatment of superficial basal cell …
https://biostock.app/symbols/BFRI
FDA Approval - Ameluz PDT for Superficial Basal Cell Carcinoma
FDA approved the sNDA for Ameluz topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for treatment of superficial basal cell …
https://biostock.app/symbols/BFRI
September 14, 2026 at 1:38 PM
🟢 #$BFRI — Regulatory Approval
FDA Approval - Ameluz PDT for Superficial Basal Cell Carcinoma
FDA approved the sNDA for Ameluz topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for treatment of superficial basal cell …
https://biostock.app/symbols/BFRI
FDA Approval - Ameluz PDT for Superficial Basal Cell Carcinoma
FDA approved the sNDA for Ameluz topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for treatment of superficial basal cell …
https://biostock.app/symbols/BFRI
🟢 #$PHAR — Regulatory Approval
FDA Approval - Joenja for Pediatric APDS Ages 4-11 (40mg/50mg doses)
FDA approved Pharming's sNDA for 40 mg and 50 mg twice-daily dosing of Joenja (leniolisib) for children aged 4 to 11 years weighing at least 27 kg with APDS, mak…
https://biostock.app/symbols/PHAR
FDA Approval - Joenja for Pediatric APDS Ages 4-11 (40mg/50mg doses)
FDA approved Pharming's sNDA for 40 mg and 50 mg twice-daily dosing of Joenja (leniolisib) for children aged 4 to 11 years weighing at least 27 kg with APDS, mak…
https://biostock.app/symbols/PHAR
September 11, 2026 at 7:05 PM
🟢 #$PHAR — Regulatory Approval
FDA Approval - Joenja for Pediatric APDS Ages 4-11 (40mg/50mg doses)
FDA approved Pharming's sNDA for 40 mg and 50 mg twice-daily dosing of Joenja (leniolisib) for children aged 4 to 11 years weighing at least 27 kg with APDS, mak…
https://biostock.app/symbols/PHAR
FDA Approval - Joenja for Pediatric APDS Ages 4-11 (40mg/50mg doses)
FDA approved Pharming's sNDA for 40 mg and 50 mg twice-daily dosing of Joenja (leniolisib) for children aged 4 to 11 years weighing at least 27 kg with APDS, mak…
https://biostock.app/symbols/PHAR
Senior Living Operator Joins BofA Real Estate Conference
The BofA Securities Global Real Estate Conference brings together real estate professionals and investors. The event…
via finance.yahoo.com
https://finance.yahoo.com/real-estate/articles/sonida-senior-living-participate-bofa-120000176.html
The BofA Securities Global Real Estate Conference brings together real estate professionals and investors. The event…
via finance.yahoo.com
https://finance.yahoo.com/real-estate/articles/sonida-senior-living-participate-bofa-120000176.html
Sonida Senior Living to Participate in the BofA Securities 2026 Global Real Estate Conference
DALLAS, September 09, 2026--Sonida Senior Living, Inc. ("Sonida" or the "Company") (NYSE: SNDA), a leading owner, operator and investor in senior living communities, announced today that Brandon Ribar, President & Chief Executive Officer and Max Levy, Chief Investment Officer, are scheduled to participate in the BofA Securities 2026 Global Real Estate Conference taking place on Tuesday, September 15th – Thursday, September 17th at the Two Bryant Park Pavilion, New York, NY.
finance.yahoo.com
September 10, 2026 at 5:21 PM
Senior Living Operator Joins BofA Real Estate Conference
The BofA Securities Global Real Estate Conference brings together real estate professionals and investors. The event…
via finance.yahoo.com
https://finance.yahoo.com/real-estate/articles/sonida-senior-living-participate-bofa-120000176.html
The BofA Securities Global Real Estate Conference brings together real estate professionals and investors. The event…
via finance.yahoo.com
https://finance.yahoo.com/real-estate/articles/sonida-senior-living-participate-bofa-120000176.html
Celcuity ($CELC) Stock Hub: sNDA Filed for the PIK3CA-Mutant Cohort, First REVTORPYK Shipments Guided for Late Quarter and Two September Fireside Chats
https://www.merlintrader.com/celc-celcuity-inc/
https://www.merlintrader.com/celc-celcuity-inc/
Celcuity ($CELC) Stock Hub: REVTORPYK Approval, Launch And Q2 2026 Financials
Celcuity ($CELC) after the July 14, 2026 FDA approval of REVTORPYK: the label, VIKTORIA-1 data, launch timing, the $575M convertible, $754.0M liquidity and the catalysts that decide the next four quarters.
www.merlintrader.com
September 6, 2026 at 7:46 PM
Celcuity ($CELC) Stock Hub: sNDA Filed for the PIK3CA-Mutant Cohort, First REVTORPYK Shipments Guided for Late Quarter and Two September Fireside Chats
https://www.merlintrader.com/celc-celcuity-inc/
https://www.merlintrader.com/celc-celcuity-inc/
CorMedix ($CRMD): What Will the First Post-TDAPA Quarter Reveal?
https://www.merlintrader.com/cormedix-therapeutics-stock-hub/
https://www.merlintrader.com/cormedix-therapeutics-stock-hub/
CorMedix (CRMD) Stock Hub: September 9 Conference, Post-TDAPA Test And REZZAYO Filing Window
Wells Fargo fireside chat confirmed for September 9 at 12:45 EDT. REZZAYO prophylaxis sNDA remains expected in Q3, while the first full post-TDAPA quarter will test DefenCath pricing and adoption. June cash of $256.7M precedes a planned $59M collateral restriction.
www.merlintrader.com
September 5, 2026 at 1:58 PM
CorMedix ($CRMD): What Will the First Post-TDAPA Quarter Reveal?
https://www.merlintrader.com/cormedix-therapeutics-stock-hub/
https://www.merlintrader.com/cormedix-therapeutics-stock-hub/
BioXcel Therapeutics filed for Chapter 11 bankruptcy with Teva positioned as the stalking-horse bidder for IGALMI and a pending agitation supplemental NDA.
BioXcel Therapeutics files Chapter 11, eyes Teva asset sale
BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
biotech.disruptsmedia.com
September 3, 2026 at 6:00 PM
BioXcel Therapeutics filed for Chapter 11 bankruptcy with Teva positioned as the stalking-horse bidder for IGALMI and a pending agitation supplemental NDA.