FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat 'Butterfly Children'
May 25, 2023 11:10 ET
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Berkshire Sterile Manufacturing
Lee, MA, May 25, 2023 (GLOBE NEWSWIRE) -- On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy...
Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA
May 23, 2023 16:00 ET
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Phathom Pharmaceuticals
Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan would be the first innovative acid...
Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma
May 17, 2023 07:00 ET
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Elevar Therapeutics
FORT LEE, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch
April 04, 2023 08:00 ET
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Phathom Pharmaceuticals
Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarterCombined commercial...
Elevar Therapeutics Announces Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option
October 11, 2022 16:00 ET
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Elevar Therapeutics
SALT LAKE CITY, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who...
Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
August 22, 2022 08:00 ET
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Minerva Neurosciences, Inc
WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
ROSEN, GLOBAL INVESTOR COUNSEL, Encourages Spero Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – SPRO
June 05, 2022 17:15 ET
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The Rosen Law Firm PA
NEW YORK, June 05, 2022 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of Spero...
Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis
May 25, 2022 08:00 ET
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., May 25, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis
March 14, 2022 08:02 ET
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., March 14, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel...
ROSEN, A LEADING NATIONAL FIRM, Encourages Fennec Pharmaceuticals Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – FENC
February 22, 2022 19:30 ET
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The Rosen Law Firm PA
NEW YORK, Feb. 22, 2022 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) between May 28,...