FDA
MRK
Nov 3
▲ +0.20
Merck Initiates Its ENHANCE-3 Phase 3 Randomized Clinical Trial Evaluating OHTUVAYRE For The Prevention Of Chronic Obstructive Pulmonary Disease
FDA
MRK
Nov 3
▲ +0.30
FDA Issues Emergency Use Authorization For Drug To Treat New World Screwworm Infestations In Dogs, Puppies
FDA
ZYDUS
Oct 27
▲ +0.30
**Tomorrow, October 27, 2026, the U.S. FDA approved Zyda Life Sciences’ ANDA-based generic entry for [Insert Generic Name Here], a move that analysts anticipate will introduce imme…
FDA
ALEMBIC
Oct 26
▲ +0.20
Alembic Pharmaceuticals has received FDA approval for drug ANDA217267, though specific details regarding the approval's subject are pending further disclosure. This development ind…
FDA
BIONPHARMA
Oct 23
▲ +0.80
Approval and launch of a short-acting insulglargine biologic for Type 1 diabetes on October 23, 2026, expand BIONPHARMA’s insulin portfolio with a differentiated formulation poised…
FDA
SANDOZ
Oct 22
▲ +0.20
Sandoz Inc. announced the submission of a Biologics License Application (BLA) by the FDA on October 22, 2026, marking a pivotal step toward commercialization whose primary market i…
FDA
NOVITIUM
Oct 15
▲ +0.70
NOVITIUM PHARMA announced the approval of its generic application, ANDA220010, on October 15, 2026. This regulatory clearance is expected to drive significant revenue growth and in…
FDA
COSETTE
Oct 15
▲ +0.60
COSETTE Pharmaceuticals has announced the authorization of a new NDA, marking its latest portfolio expansion following the 2026 product launch. Financial analysts anticipate this s…
FDA
AMNEAL
Oct 15
▲ +0.20
Amneal Pharmaceuticals announced Friday that its ANDA-approved product is now available on the U.S. market, marking a new competitive entry for the corresponding branded therapy. T…
FDA
HUMANWELL
Oct 14
▲ +0.80
Humanwell Puracap announced today that the FDA approved its ANDA221049, paving the way for the launch of a generic alternative as the market moves into 2026. This regulatory approv…
FDA
STRIDES
Oct 13
▼ -0.60
**STRIDES PHARMA INTL** announced that on October 13, 2026, the FDA approved its Abbreviated New Drug Application (ANDA #208359), which is expected to allow for the late-entry mark…
FDA
AICURIS
Oct 9
▲ +0.80
The FDA has approved a new treatment from Aicuris Anti-Infective Cures AG aimed at addressing identified health needs effective October 9, 2026, potentially transforming market dyn…
FDA
LUPIN
Sep 30
▲ +0.20
Lupin announced the receipt of final FDA approval for a Abbreviated New Drug Application, signaling a potential entry into a valued therapeutic market. This regulatory clearance is…
FDA
TARO
Sep 30
▲ +0.50
Taro Pharmaceutical Industries announced FDA approval of the pending ANDA220722, signaling the final regulatory step in securing market entry; this clearance sets the stage for Tar…
FDA
ZYDUS
Sep 29
▲ +0.50
FDA has granted approval to Zydus Lifesciences under ANDA 218361, paving the way for the manufacturer to potentially enter a new market segment and challenge competitors with the l…
FDA
UPSHER
Sep 28
▲ +0.50
Uppersmith Labs announced the FDA approval of its ANDA for the generic drug on September 28, 2026, setting the stage for imminent market entry. This filing is expected to drive dil…
FDA
NEPHRON
Sep 28
▼ -0.80
NEPHRON has obtained FDA approval for its Abbreviated New Drug Application (ANDA216254), paving the way for a generic entry that is expected to significantly undermine the market d…
FDA
MRK
Sep 25
— 0.00
Merck Receives FDA Approval For Its Dual Oral Regimen Of WELIREG Plus LENMIVA For The Treatment Of Adult Patients With Advanced Renal Cell Carcinoma With A Clear Cell Component
FDA
JNJ
Sep 25
— 0.00
Johnson & Johnson Announces That TREMFYA Met Primary And Major Secondary Endpoints Demonstrating Both Improvement In Axial Symptoms And Reduction In Inflammation By MRI Assessment …
FDA
YICHANG
Sep 25
— 0.00
Despite the preliminary designation, YICHANG HUMANWELL’s anticipated FDA approval for the generic version of this unspecified therapeutic, targeted for September 25, 2026, is expec…