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Mon, Aug 17
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REGULATORY & CLINICAL>FDA/APPROVAL

43 headlines · 20260817
GLOBE_NEWS_WIRE22:367m ago

H2O America Receives Regulatory Approval for Texas Subsidiary’s Acquisition of Quadvest

H2O America Receives Regulatory Approval for Texas Subsidiary’s Acquisition of Quadvest | SAN JOSE, Calif. and MAGNOLIA, Texas, Aug. 17, 2026 (GLOBE NEWSWIRE) -- H2O America (NASDAQ: HTO) today announced that its regulated Texas water and wastewater utility, The Texas Water Company, Inc. (“TWC”), a…
M&A / ACQUISITIONREGULATORY & CLINICAL / FDA/APPROVALREGULATORY & CLINICAL / REGULATORY
DOW_JONES22:367m ago

Press Release: H2O America Receives Regulatory Approval for Texas Subsidiary's Acquisition of Quadvest

Press Release: H2O America Receives Regulatory Approval for Texas Subsidiary's Acquisition of Quadvest | SAN JOSE, Calif. and MAGNOLIA, Texas, Aug. 17, 2026 (GLOBE NEWSWIRE) -- H2O America (NASDAQ: HTO) today announced that its regulated Texas water and wastewater utility, The Texas Water Company,…
M&A / ACQUISITIONREGULATORY & CLINICAL / FDA/APPROVALREGULATORY & CLINICAL / REGULATORY
BENZINGA20:082h agobullish

XP's Board Of Directors Approves The Cancellation Of Existing Treasury Class A Shares Held By The Company; Total Share Count Went From 520,292,030 To 508,500,275 After Cancellation

XP's Board Of Directors Approves The Cancellation Of Existing Treasury Class A Shares Held By The Company; Total Share Count Went From 520,292,030 To 508,500,275 After Cancellation | 4:08 PM EDT, August 17, 2026 (Benzinga Newswire) XP Inc. (NASDAQ:XP), announced today that its board of directors ha…
REGULATORY & CLINICAL / FDA/APPROVAL
BUSINESS_WIRE19:442h agobullish

Nanochon Receives Regulatory Approval from Panamá’s Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™

Nanochon Receives Regulatory Approval from Panamá’s Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™ | WASHINGTON--(BUSINESS WIRE)-- Nanochon, a medical device company developing Chondrograft™, a novel patented implant for the treatment of articular cartilage defects of…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVALREGULATORY & CLINICAL / REGULATORY
MIDNIGHT_TRADER18:214h agobullish

Update: Almonty Industries Shares Rise After Board Approves $300 Million Buyback Plan

Update: Almonty Industries Shares Rise After Board Approves $300 Million Buyback Plan | 02:21 PM EDT, 08/17/2026 (MT Newswires) -- (Updates with the latest stock movement in the first paragraph and headline.) Almonty Industries (ALM) shares were up over 7% in Monday trading after the company said i…
REGULATORY & CLINICAL / FDA/APPROVALSHAREHOLDER RETURNS / BUYBACK
PR_NEWS_WIRE15:586h agobullish

Lupin Announces Approval from U.S. FDA for Pitolisant Tablets

Lupin Announces Approval from U.S. FDA for Pitolisant Tablets | MUMBAI, India and NAPLES, Fla., Aug. 17, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received the final approval…
REGULATORY & CLINICAL / FDA/APPROVAL
BENZINGA15:327h ago

Shares of crypto-linked companies are trading higher amid a rise in Bitcoin. Catalysts may include the Trump family's crypto business, World Liberty Financial, receiving conditional approval to establish a bank, and expectations that President Trump will attend a meeting with crypto and prediction market executives on August 19.

Shares of crypto-linked companies are trading higher amid a rise in Bitcoin. Catalysts may include the Trump family's crypto business, World Liberty Financial, receiving conditional approval to establish a bank, and expectations that President Trump will attend a meeting with crypto and prediction…
REGULATORY & CLINICAL / FDA/APPROVALMARKETS & TRADING / CRYPTO
DOW_JONES14:168h agobearish

Faeth Therapeutics Shares Rise on FDA Fast-Track Designation for Cancer Treatment

Faeth Therapeutics Shares Rise on FDA Fast-Track Designation for Cancer Treatment | Faeth Therapeutics shares rose Monday morning after the clinical-stage oncology company said the Food and Drug Administration granted fast-track designation to its experimental cancer treatment. Shares were recently…
REGULATORY & CLINICAL / FDA/APPROVAL
GLOBE_NEWS_WIRE12:1510h agobullish

VivoPower Approves Independent Listing of 2.2GW Non-Nordic AI Infrastructure Platform, Transferring Capital Expenditure Requirements Whilst Retaining De Facto Control

VivoPower Approves Independent Listing of 2.2GW Non-Nordic AI Infrastructure Platform, Transferring Capital Expenditure Requirements Whilst Retaining De Facto Control | VivoPower team has assembled a non-Nordic portfolio and pipeline in excess of 2.2GW across the GCC and ASEAN regions through sover…
REGULATORY & CLINICAL / FDA/APPROVALTECH/AI / AI & SEMICONDUCTORS
BENZINGA12:0910h agobullish

FDA Conditionally Accepts Acurx Pharmaceuticals' Brand Name CIFBEZY for Ibezapolstat

FDA Conditionally Accepts Acurx Pharmaceuticals' Brand Name CIFBEZY for Ibezapolstat | 8:09 AM EDT, August 17, 2026 (Benzinga Newswire) The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO These in…
REGULATORY & CLINICAL / FDA/APPROVAL
MIDNIGHT_TRADER12:0710h agobullish

Almonty Industries Approves $300 Million Buyback Program

Almonty Industries Approves $300 Million Buyback Program | 08:07 AM EDT, 08/17/2026 (MT Newswires) -- Almonty Industries (ALM) said Monday that its board of directors has approved a new share repurchase program of up to $300 million. The company said the program allows the purchase of up to 14.4 mi…
REGULATORY & CLINICAL / FDA/APPROVALSHAREHOLDER RETURNS / BUYBACK
PR_NEWS_WIRE12:0110h agobullish

Acurx Pharmaceuticals Receives FDA Conditional Acceptance and USPTO Trademark Allowance for the Company's Brand Name for Ibezapolstat

Acurx Pharmaceuticals Receives FDA Conditional Acceptance and USPTO Trademark Allowance for the Company's Brand Name for Ibezapolstat | The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO These in…
REGULATORY & CLINICAL / FDA/APPROVAL
MIDNIGHT_TRADER11:3811h agobullish

Castle Biosciences Gets Approval for Dual Listing on Nasdaq Texas

Castle Biosciences Gets Approval for Dual Listing on Nasdaq Texas | 07:38 AM EDT, 08/17/2026 (MT Newswires) -- Castle Biosciences (CSTL) has received approval for the dual listing of its common stock on Nasdaq Texas, in addition to its primary listing on the Nasdaq Global Market, the company said M…
REGULATORY & CLINICAL / FDA/APPROVAL
BENZINGA11:3611h agobullish

Radiopharm Theranostics Schedules An FDA End-Of-Phase 2 For October 1, 2026, To Align On The Design Of A Pivotal Phase 3 Trial To Evaluate RAD101 In Patients With Suspected Recurrence Of Brain Metastases Following Radiotherapy

Radiopharm Theranostics Schedules An FDA End-Of-Phase 2 For October 1, 2026, To Align On The Design Of A Pivotal Phase 3 Trial To Evaluate RAD101 In Patients With Suspected Recurrence Of Brain Metastases Following Radiotherapy | 7:36 AM EDT, August 17, 2026 (Benzinga Newswire) RAD101 is the Company…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL
BENZINGA11:3511h agobullish

Almonty Industries Board Approves $300M Share Repurchase Program

Almonty Industries Board Approves $300M Share Repurchase Program | 7:35 AM EDT, August 17, 2026 (Benzinga Newswire) Repurchase Program Aims to Create Shareholder Value by Capturing Disconnect Between Share Price and Value of Almonty’s Strategic Tungsten Assets and Growth Prospects Ahead of Initial…
REGULATORY & CLINICAL / FDA/APPROVALSHAREHOLDER RETURNS / BUYBACK
BENZINGA11:3311h agobearish

Faeth Therapeutics Says FDA Grants Fast Track Designation To Combination Of Sapanisertib And Serabelisib With Paclitaxel For Treatment Of Patients With Endometrial Cancer

Faeth Therapeutics Says FDA Grants Fast Track Designation To Combination Of Sapanisertib And Serabelisib With Paclitaxel For Treatment Of Patients With Endometrial Cancer | 7:33 AM EDT, August 17, 2026 (Benzinga Newswire) — Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in…
REGULATORY & CLINICAL / FDA/APPROVAL
PR_NEWS_WIRE11:3111h agobullish

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market | Common Stock Expected to Begin Trading on or about August 18, 2026 Under the Ticker Symbol "ADBT" TOKYO and NEW YORK, Aug. 17, 2026 /PRNewswire/ -- Advasa Holdings…
REGULATORY & CLINICAL / FDA/APPROVAL
GLOBE_NEWS_WIRE11:3011h agobullish

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases | RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 meeting with t…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL
BUSINESS_WIRE11:3011h agobearish

Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer

Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer | — Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or rec…
REGULATORY & CLINICAL / FDA/APPROVAL
GLOBE_NEWS_WIRE11:3011h agobullish

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market | TOKYO and NEW YORK, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Advasa Holdings, Inc. (“ADVASA” or the “Company”), a fintech payment holding company providing Earned Wage Ac…
REGULATORY & CLINICAL / FDA/APPROVAL
BUSINESS_WIRE11:3011h agobullish

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market

Advasa Holdings, Inc. Announces Effectiveness of Registration Statement and Approval to List Common Stock on the Nasdaq Global Market | Common Stock Expected to Begin Trading on or about August 18, 2026 Under the Ticker Symbol “ADBT” TOKYO & NEW YORK--(BUSINESS WIRE)-- Advasa Holdings, Inc. (“ADVAS…
REGULATORY & CLINICAL / FDA/APPROVAL
DOW_JONES11:0011h agobullish

Press Release: Pulsenmore Receives Second AI Grant Within One Month: Israel Innovation Authority Approves $1.27 Million for SmartScan AI Program

Press Release: Pulsenmore Receives Second AI Grant Within One Month: Israel Innovation Authority Approves $1.27 Million for SmartScan AI Program | The new grant brings the total AI grants approved for Pulsenmore over the past month to approximately $1.6 million, supporting two programs with a combi…
GEOPOLITICS / WAR/CONFLICTREGULATORY & CLINICAL / FDA/APPROVAL
PR_NEWS_WIRE11:0011h agobullish

Pulsenmore Receives Second AI Grant Within One Month: Israel Innovation Authority Approves $1.27 Million for SmartScan AI Program

Pulsenmore Receives Second AI Grant Within One Month: Israel Innovation Authority Approves $1.27 Million for SmartScan AI Program | The new grant brings the total AI grants approved for Pulsenmore over the past month to approximately $1.6 million, supporting two programs with a combined scope of ap…
GEOPOLITICS / WAR/CONFLICTREGULATORY & CLINICAL / FDA/APPROVAL
PR_NEWS_WIRE11:0011h agobullish

Castle Biosciences Approved for Dual Listing on Nasdaq Texas

Castle Biosciences Approved for Dual Listing on Nasdaq Texas | FRIENDSWOOD, Texas, Aug. 17, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been approved to have its common stock d…
REGULATORY & CLINICAL / FDA/APPROVAL
BENZINGA05:2217h agobullish

Argenx's Efgartigimod Becomes First Phase 3 Therapy To Show Statistically Significant, Clinically Meaningful Improvement In IMNM, A Subtype With No Approved Treatment

Argenx's Efgartigimod Becomes First Phase 3 Therapy To Show Statistically Significant, Clinically Meaningful Improvement In IMNM, A Subtype With No Approved Treatment | 1:22 AM EDT, August 17, 2026 (Benzinga Newswire) Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in th…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL